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

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..

Clearance details

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

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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.