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510(k) K771843

WETTING AGENTS by Gamma Enterprises, Inc.

K771843 is an FDA 510(k) premarket notification submitted by Gamma Enterprises, Inc. for the device "WETTING AGENTS". The FDA issued a decision of Substantially Equivalent on November 22, 1977. Gamma Enterprises, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1977
Date Received
September 21, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Gamma Enterprises, Inc.

  • K790578 — GAMMA SMAC REAGENTS (May 15, 1979)
  • K780507 — SERUM GLUTAMIC-PYRUVIC TRANSAMINASE (May 3, 1978)
  • K780506 — CARBON DIOXIDE REAGENTS (May 3, 1978)
  • K780504 — CREATINE PHOSPHOKINASE (CPK) (May 3, 1978)
  • K780505 — SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE (May 3, 1978)
  • K771832 — CHLORIDE (November 22, 1977)
  • K771836 — LACTATE DEHYDROGENASE (November 22, 1977)
  • K771834 — CREATININE (November 3, 1977)
  • K771838 — SERUM IRON (November 3, 1977)
  • K771829 — ALKALINE PHOSPHATASE (November 2, 1977)

FDA data resources