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FDA 510(k)

COMBO MASK

K-Number: K941336 · 1994-09-09

ApplicantGam Industries, Inc.
Decision Date1994-09-09
Product CodeKGB
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

COMBO MASK is the device name listed in this FDA 510(k) record. The listed applicant is Gam Industries, Inc.. It received FDA 510(k) clearance on 1994-09-09 under 510(k) number K941336. The device is classified under product code KGB. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMBO MASK?

COMBO MASK is a medical device that received FDA 510(k) clearance on 1994-09-09. The listed applicant is Gam Industries, Inc.. The 510(k) number is K941336.

When did COMBO MASK receive FDA 510(k) clearance?

COMBO MASK received FDA 510(k) clearance on 1994-09-09, under 510(k) number K941336.

Who is the listed applicant for COMBO MASK?

The FDA 510(k) record lists Gam Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMBO MASK?

The FDA product code for COMBO MASK is KGB.

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Other records listing Gam Industries, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K941641DISPOSABLE EMERGENCY OBSTETRICAL KITK942021MOUTH TO MOUTH BREATHERK936050JAW SPREADERK930401ALUMINUM FOILK926290BURN SHEETK925590MULTI-TRAUMA DRESSING

View all 9 devices →

Related Devices (Code: KGB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K970688POCKET RESCUECheen Houng Ent. Co. , Ltd.K960401ULTIMATE SEALHans Rudolph, Inc.K935917CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVESBd Becton Dickinson Vacutainer Systems PreanalyticK932347COMPACT MASKVital Signs, Inc.K933583NONREBREATHING VALVEHans Rudolph, Inc.K933048LAERDAL(TM) POCKET MASK, MODIFICATIONLaerdal Medical Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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