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510(k) K942275

VIAL VENT FILTER by Gelman Sciences, Inc. — Product Code FPB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 1994
Date Received
May 10, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Infusion Line
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Gelman Sciences, Inc.

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  • K941589 — SYRINGE FILTER DEVICES (September 6, 1994)
  • K941020 — DRUG RECONSTITUTION FILTER DEVICE (August 10, 1994)
  • K941032 — UNKNOWN (May 27, 1994)
  • K910821 — TRANSDUCER PROTECTOR (August 12, 1991)
  • K892387 — MODIFIED GELMAN ARTERIAL FILTER (June 22, 1989)
  • K884176 — CHROMATOGRAPHY KIT (April 4, 1989)
  • K884178 — DRUG CONTROL SET (February 17, 1989)
  • K884177 — DRUG STANDARD SET (February 17, 1989)

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  • K941628 — 40 MICRON BLOOD TRANSFUSION FILTER (February 16, 1995)