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FDA 510(k)

FOIL BABY BUNTING

K-Number: K915303 · 1992-02-20

ApplicantGam Industries, Inc.
Decision Date1992-02-20
Product CodeKME
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FOIL BABY BUNTING 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 1992-02-20 under 510(k) number K915303. The device is classified under product code KME. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FOIL BABY BUNTING?

FOIL BABY BUNTING is a medical device that received FDA 510(k) clearance on 1992-02-20. The listed applicant is Gam Industries, Inc.. The 510(k) number is K915303.

When did FOIL BABY BUNTING receive FDA 510(k) clearance?

FOIL BABY BUNTING received FDA 510(k) clearance on 1992-02-20, under 510(k) number K915303.

Who is the listed applicant for FOIL BABY BUNTING?

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 FOIL BABY BUNTING?

The FDA product code for FOIL BABY BUNTING is KME.

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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 KITK941336COMBO MASKK942021MOUTH TO MOUTH BREATHERK936050JAW SPREADERK930401ALUMINUM FOILK926290BURN SHEET

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Related Devices (Code: KME)

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.

K042145READY-HEAT BLANKETTechtrade, LLCK944953OREX MEDICAL BEDDINGThantex Specialties, Inc.K933636DISPOSE-A-SHEETBelmac Healthcare Corp.K932539DOCTOR DOWN --RESCUE WRAPThree Dog DownK922143AMERICAN BURN SHEETAmerican Silk Sutures, Inc.K912257CHEM-SLEEVE BHaz-Med, Inc.

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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