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FDA 510(k)

MULTIPLE BURN DRESSING

K-Number: K914071 · 1991-12-04

ApplicantKerma Medical Products, Inc.
Decision Date1991-12-04
Product CodeNAB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MULTIPLE BURN DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Kerma Medical Products, Inc.. It received FDA 510(k) clearance on 1991-12-04 under 510(k) number K914071. The device is classified under product code NAB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MULTIPLE BURN DRESSING?

MULTIPLE BURN DRESSING is a medical device that received FDA 510(k) clearance on 1991-12-04. The listed applicant is Kerma Medical Products, Inc.. The 510(k) number is K914071.

When did MULTIPLE BURN DRESSING receive FDA 510(k) clearance?

MULTIPLE BURN DRESSING received FDA 510(k) clearance on 1991-12-04, under 510(k) number K914071.

Who is the listed applicant for MULTIPLE BURN DRESSING?

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

What is the FDA product code for MULTIPLE BURN DRESSING?

The FDA product code for MULTIPLE BURN DRESSING is NAB.

Related Clinical Trials

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.

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Other records listing Kerma Medical Products, 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.

K931042MOORE SECURE CAPK915821MULTIPLE STERILE GAUZE BANDAGE ROLLS, VARI SIZESK915822MULTIPLE DRESSING, STERILE NONADDHERENT PADSK914937STERILE BANDAGE, GAUZE, FINE MESH, 3X8 INCHES

Related Devices (Code: NAB)

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.

K946015IVALON EXTERNAL SPONGEIvalonK940755ISOLYER (4X4, 8PLY)Isolyer Co.K931610OMNISORB II, NONWOVEN SPONGE, STERILE AND NONOmni Mfg., Inc.K925590MULTI-TRAUMA DRESSINGGam Industries, Inc.K926072K-BAND AND K-CREPEParema , Ltd.K915591STERILE GAUZE PADSEagle Medical, Inc.

Official Source

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

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