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510(k) K813159

VACUSHIELD TM by Gelman Sciences, Inc. — Product Code JRL

K813159 is an FDA 510(k) premarket notification submitted by Gelman Sciences, Inc. for the device "VACUSHIELD TM". The FDA issued a decision of Substantially Equivalent on December 8, 1981. The device falls under product code JRL (Unit, Filter, Membrane), a Class I device regulated under 21 CFR 862.2050. Gelman Sciences, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 1981
Date Received
November 16, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Filter, Membrane
Device Class
Class I
Regulation Number
862.2050
Review Panel
CH
Submission Type

Other clearances by Gelman Sciences, Inc.

  • K946190 — DRUG DISPENSING SPIKE (March 17, 1995)
  • K943127 — PHARMASSURE LARGE VOLUME TRANSFER FILTERS (September 29, 1994)
  • K941589 — SYRINGE FILTER DEVICES (September 6, 1994)
  • K941020 — DRUG RECONSTITUTION FILTER DEVICE (August 10, 1994)
  • K942275 — VIAL VENT FILTER (July 26, 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)

Other clearances for product code JRL

  • K822121 — ACRO PACK (August 5, 1982)
  • K820455 — CENTRIFREE MICROPARTITION SYSTEM (March 15, 1982)
  • K820224 — EMIT FREELEVEL SYSTEM I (February 23, 1982)
  • K812750 — IL 703, STAT SEPARATOR (January 26, 1982)
  • K810829 — ACRODISC (April 8, 1981)
  • K801500 — ULTRAFREE CALCIUM FILTER (August 20, 1980)
  • K790445 — ULTRA-FREE (June 28, 1979)
  • K781043 — CEA-IMMERSIBLE SEPARATOR (September 15, 1978)

FDA data resources