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510(k) K941336

COMBO MASK by Gam Industries, Inc. — Product Code KGB

K941336 is an FDA 510(k) premarket notification submitted by Gam Industries, Inc. for the device "COMBO MASK". The FDA issued a decision of Substantially Equivalent on September 9, 1994. The device falls under product code KGB (Mask, Oxygen, Non-Rebreathing), a Class I device regulated under 21 CFR 868.5570. Gam Industries, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1994
Date Received
March 21, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mask, Oxygen, Non-Rebreathing
Device Class
Class I
Regulation Number
868.5570
Review Panel
AN
Submission Type

Other clearances by Gam Industries, Inc.

  • K941641 — DISPOSABLE EMERGENCY OBSTETRICAL KIT (October 3, 1994)
  • K942021 — MOUTH TO MOUTH BREATHER (June 22, 1994)
  • K936050 — JAW SPREADER (March 24, 1994)
  • K930401 — ALUMINUM FOIL (May 12, 1993)
  • K926290 — BURN SHEET (April 20, 1993)
  • K925590 — MULTI-TRAUMA DRESSING (April 8, 1993)
  • K915569 — UMBILICAL CLAMP (September 23, 1992)
  • K915303 — FOIL BABY BUNTING (February 20, 1992)

Other clearances for product code KGB

  • K970688 — POCKET RESCUE (September 26, 1997)
  • K960401 — ULTIMATE SEAL (June 20, 1996)
  • K935917 — CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVES (February 4, 1994)
  • K932347 — COMPACT MASK (January 10, 1994)
  • K933583 — NONREBREATHING VALVE (January 3, 1994)
  • K933048 — LAERDAL(TM) POCKET MASK, MODIFICATION (December 2, 1993)
  • K930336 — PROFAST(R)-DENTURE ADHESIVE CREAM (August 24, 1993)
  • K913164 — NON REBREATHING MASK (January 15, 1992)
  • K883766 — MOUTH-TO-MASK VENTILATORY ADJUNCT (October 21, 1988)
  • K790161 — OXYGEN MASK W/RESERVOIR BAG (April 20, 1979)

FDA data resources