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FDA 510(k)

CERTIBURN BURN/TRAUMA FACE DRESSING, TOWEL DRESSING

K-Number: K946338 · 1995-03-29

ApplicantCertified Safety Mfg., Inc.
Decision Date1995-03-29
Product CodeMGP
DecisionSubstantially Equivalent

Device Summary

CERTIBURN BURN/TRAUMA FACE DRESSING, TOWEL DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Certified Safety Mfg., Inc.. It received FDA 510(k) clearance on 1995-03-29 under 510(k) number K946338. The device is classified under product code MGP. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CERTIBURN BURN/TRAUMA FACE DRESSING, TOWEL DRESSING?

CERTIBURN BURN/TRAUMA FACE DRESSING, TOWEL DRESSING is a medical device that received FDA 510(k) clearance on 1995-03-29. The listed applicant is Certified Safety Mfg., Inc.. The 510(k) number is K946338.

When did CERTIBURN BURN/TRAUMA FACE DRESSING, TOWEL DRESSING receive FDA 510(k) clearance?

CERTIBURN BURN/TRAUMA FACE DRESSING, TOWEL DRESSING received FDA 510(k) clearance on 1995-03-29, under 510(k) number K946338.

Who is the listed applicant for CERTIBURN BURN/TRAUMA FACE DRESSING, TOWEL DRESSING?

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

What is the FDA product code for CERTIBURN BURN/TRAUMA FACE DRESSING, TOWEL DRESSING?

The FDA product code for CERTIBURN BURN/TRAUMA FACE DRESSING, TOWEL DRESSING is MGP.

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Other records listing Certified Safety Mfg., 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.

K960587CPROTECTOR 2000K960615GAUZE COMPRESSK960624CERTI COOL INSTANT COLD COMPRESSK953102BLOODBORNE PATHOGEN KITK9450021X6YD, 2X6YD, 4X6YD ROLL BANDAGEK9450042, 3 & 4 BANDADGE COMPRESS

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Related Devices (Code: MGP)

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.

K012995COLLATEK SHEETBiocore Medical Technologies, Inc.K012997COLLATEK FOAMBiocore Medical Technologies, Inc.K001508LASERSKIN DRESSINGFidia Advanced Biopolymers SrlK990079FASTSEAL CHEST WOUND DRESSINGGreenfield Medical Technologies, Inc.K991214SIMPLICARE TRANSPARENT WOUND DRESSINGHollister, Inc.K992302DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORSDermaphylyx, 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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