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FDA 510(k)

NOVA GAUZE

K-Number: K830473 · 1983-04-15

ApplicantAmerican Threshold Industries, Inc.
Decision Date1983-04-15
Product CodeNAB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NOVA GAUZE is the device name listed in this FDA 510(k) record. The listed applicant is American Threshold Industries, Inc.. It received FDA 510(k) clearance on 1983-04-15 under 510(k) number K830473. 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 NOVA GAUZE?

NOVA GAUZE is a medical device that received FDA 510(k) clearance on 1983-04-15. The listed applicant is American Threshold Industries, Inc.. The 510(k) number is K830473.

When did NOVA GAUZE receive FDA 510(k) clearance?

NOVA GAUZE received FDA 510(k) clearance on 1983-04-15, under 510(k) number K830473.

Who is the listed applicant for NOVA GAUZE?

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

What is the FDA product code for NOVA GAUZE?

The FDA product code for NOVA GAUZE is NAB.

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Other records listing American Threshold Industries, Inc. as applicant

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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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