COMBO MASK— 510(k) K941336

Substantially Equivalent

Gam Industries, Inc.

FDA 510(k) clearance K941336 for COMBO MASK, Substantially Equivalent on 1994-09-09. Applicant: Gam Industries, Inc.. Device class: 1.

Clearance details

Applicant: Gam Industries, Inc.
Product code: Code KGB
Device class: Class 1
Regulation: 21 CFR 868.5570
Advisory panel: Anesthesiology
Date received: 1994-03-21
Decision date: 1994-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Petersburg, VA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KGB

K970688 — POCKET RESCUE1997-09-26
K960401 — ULTIMATE SEAL1996-06-20
K935917 — CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVES1994-02-04
K932347 — COMPACT MASK1994-01-10
K933583 — NONREBREATHING VALVE1994-01-03

More clearances from Gam Industries, Inc.

K941641 — DISPOSABLE EMERGENCY OBSTETRICAL KIT1994-10-03
K942021 — MOUTH TO MOUTH BREATHER1994-06-22
K936050 — JAW SPREADER1994-03-24
K930401 — ALUMINUM FOIL1993-05-12
K926290 — BURN SHEET1993-04-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.