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FDA 510(k)

12-PLY GAUZE PAD

K-Number: K912951 · 1991-09-10

ApplicantCal West Trading Co.
Decision Date1991-09-10
Product CodeNAB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

12-PLY GAUZE PAD is the device name listed in this FDA 510(k) record. The listed applicant is Cal West Trading Co.. It received FDA 510(k) clearance on 1991-09-10 under 510(k) number K912951. 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 12-PLY GAUZE PAD?

12-PLY GAUZE PAD is a medical device that received FDA 510(k) clearance on 1991-09-10. The listed applicant is Cal West Trading Co.. The 510(k) number is K912951.

When did 12-PLY GAUZE PAD receive FDA 510(k) clearance?

12-PLY GAUZE PAD received FDA 510(k) clearance on 1991-09-10, under 510(k) number K912951.

Who is the listed applicant for 12-PLY GAUZE PAD?

The FDA 510(k) record lists Cal West Trading Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 12-PLY GAUZE PAD?

The FDA product code for 12-PLY GAUZE PAD is NAB.

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Other records listing Cal West Trading Co. 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.

K9503924-O2 PLUS (CPR) MOUTH BARRIER, CATALOG NO. 08050K933756MAGNASHIELD CPR MOUTH BARRIERK920269EZ GAUZE SPONGEK914842GAUZE BANDAGE ROLLK912950COMPRESS DRESSINGK912952BANDAGE COMPRESS

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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

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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