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510(k) K875362

BREWER GEL FOR ANAEROBES by Fairleigh Dickinson Laboratories, Inc. — Product Code KZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1988
Date Received
December 31, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Gas Generating
Device Class
Class I
Regulation Number
866.2580
Review Panel
MI
Submission Type

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  • K881502 — BREWER GEL FOR CAMPYLOBACTER (April 27, 1988)
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  • K850251 — ROTALOK SURGICAL HAND TABLE (February 28, 1985)

Other clearances for product code KZJ

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  • K872782 — BBL(R) GASPAK CO2 POUCH(TM) (August 6, 1987)
  • K871709 — ANAEROBIC TRANSPORT POUCH (CATALYST-FREE) (May 15, 1987)
  • K871238 — ANABAG (April 3, 1987)
  • K862123 — BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE (June 16, 1986)
  • K853534 — BBL CAMPY POUCH (August 29, 1985)
  • K845008 — BIO-BAG ENVIRONMENTAL CHAMBER -TYPE A-MULTI-PLATE (March 5, 1985)
  • K844571 — CAMPYPAK PLUS W/PALLADIUM CATALYST DISPOS. HYDROGE (January 30, 1985)
  • K841117 — GASPAK PLUS DISPOS. HYDROGEN & (April 4, 1984)
  • K832229 — BBL ANAGEL POWDER (August 12, 1983)