PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM— 510(k) K884357

Name: FDA 510(k) clearance K884357
Creator: U.S. Food and Drug Administration
Published: 1988-11-01

Substantially Equivalent

Precision Dynamics Corp.

FDA 510(k) clearance K884357 for PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM, Substantially Equivalent on 1988-11-01. Applicant: Precision Dynamics Corp.. Device class: 1.

Clearance details

Applicant: Precision Dynamics Corp.
Product code: Code KOT
Device class: Class 1
Regulation: 21 CFR 872.3490
Advisory panel: Dental
Date received: 1988-10-17
Decision date: 1988-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Van Nuys, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KOT

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K945462 — SUPER POLI-GRIP DENTURE ADHESIVE CREAM1994-12-20
K941365 — MPI DENTURE ADHESIVE FILM SEALS1994-04-22
K903568 — SUPER STRENGTH DENTURE ADHESIVE CREAM1990-10-24
K895818 — STEADFAST DENTURE ADHESIVE CREAM1990-04-03
K872225 — SUPER POLI-GRIP & WERNET'S DENTURE ADHES. POWDER1987-06-30

More clearances from Precision Dynamics Corp.

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K020718 — SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE2002-06-03
K994353 — SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #35652000-03-22
K994263 — SECURLINE UMBILICAL CORD CLAMP CLIPPER #35402000-01-24
K990737 — 'ECURLINE UMBILICAL CORD CLAMP #35001999-04-06
K882580 — MECHANICAL CHANGE IN IN-VITRO MICRO DEVICE1988-07-08

Adverse events under product code KOT

product code KOT

Death: 5
Injury: 309
Total: 314

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.