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510(k) K770082

SALONMAY BUSTLINE INCREASER by Gamma Enterprises, Inc. — Product Code MWZ

K770082 is an FDA 510(k) premarket notification submitted by Gamma Enterprises, Inc. for the device "SALONMAY BUSTLINE INCREASER". The FDA issued a decision of Substantially Equivalent on March 16, 1977. The device falls under product code MWZ (Expander, Breast, External), a Class I device regulated under 21 CFR 890.5660. Gamma Enterprises, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1977
Date Received
January 14, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Expander, Breast, External
Device Class
Class I
Regulation Number
890.5660
Review Panel
SU
Submission Type

Other clearances by Gamma Enterprises, Inc.

  • K790578 — GAMMA SMAC REAGENTS (May 15, 1979)
  • K780504 — CREATINE PHOSPHOKINASE (CPK) (May 3, 1978)
  • K780507 — SERUM GLUTAMIC-PYRUVIC TRANSAMINASE (May 3, 1978)
  • K780506 — CARBON DIOXIDE REAGENTS (May 3, 1978)
  • K780505 — SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE (May 3, 1978)
  • K771836 — LACTATE DEHYDROGENASE (November 22, 1977)
  • K771843 — WETTING AGENTS (November 22, 1977)
  • K771832 — CHLORIDE (November 22, 1977)
  • K771838 — SERUM IRON (November 3, 1977)
  • K771834 — CREATININE (November 3, 1977)

FDA data resources