OPTIPHOR-10— 510(k) K842560

Substantially Equivalent

Gelman Sciences, Inc.

FDA 510(k) clearance K842560 for OPTIPHOR-10, Substantially Equivalent on 1984-08-10. Applicant: Gelman Sciences, Inc.. Device class: 1.

Clearance details

Applicant: Gelman Sciences, Inc.
Product code: Code JJN
Device class: Class 1
Regulation: 21 CFR 862.2485
Advisory panel: Clinical Chemistry
Date received: 1984-07-02
Decision date: 1984-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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K882163 — HELENA REP GEL PROCESSOR1988-06-20

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K941020 — DRUG RECONSTITUTION FILTER DEVICE1994-08-10
K942275 — VIAL VENT FILTER1994-07-26

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