PRE-BYPASS FILTER— 510(k) K812539

Substantially Equivalent

Gelman Sciences, Inc.

FDA 510(k) clearance K812539 for PRE-BYPASS FILTER, Substantially Equivalent on 1981-10-13. Applicant: Gelman Sciences, Inc.. Device class: 2.

Clearance details

Applicant: Gelman Sciences, Inc.
Product code: Code KRJ
Device class: Class 2
Regulation: 21 CFR 870.4280
Advisory panel: Cardiovascular
Date received: 1981-09-03
Decision date: 1981-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Gelman Sciences, Inc.

K946190 — DRUG DISPENSING SPIKE1995-03-17
K943127 — PHARMASSURE LARGE VOLUME TRANSFER FILTERS1994-09-29
K941589 — SYRINGE FILTER DEVICES1994-09-06
K941020 — DRUG RECONSTITUTION FILTER DEVICE1994-08-10
K942275 — VIAL VENT FILTER1994-07-26

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