PRE-DENT SYSTEM OR PRE-DENT II— 510(k) K801386

Substantially Equivalent

Pre-Dent System

FDA 510(k) clearance K801386 for PRE-DENT SYSTEM OR PRE-DENT II, Substantially Equivalent on 1980-07-14. Applicant: Pre-Dent System. Device class: 1.

Clearance details

Applicant: Pre-Dent System
Product code: Code KSS
Device class: Class 1
Regulation: 21 CFR 864.9050
Advisory panel: Hematology
Date received: 1980-06-13
Decision date: 1980-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Recent devices under product code KSS

K874436 — FLUID SAMPLING PACK1988-01-05
K812892 — S/P SERUM DROPPER PIPETS1981-10-27
K801516 — PRE-DENT SYSTEM MODIFIED1980-07-14
K800736 — PRE-DENT SYSTEM1980-04-24
K761303 — IMMU-SAL IMMUNOHEMATOLOGICAL SALINE1976-12-30

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