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FDA 510(k)

NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE

K-Number: K915530 · 1992-08-17

ApplicantAmerican Threshold Industries, Inc.
Decision Date1992-08-17
Product CodeHAX
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE 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 1992-08-17 under 510(k) number K915530. The device is classified under product code HAX. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE?

NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE is a medical device that received FDA 510(k) clearance on 1992-08-17. The listed applicant is American Threshold Industries, Inc.. The 510(k) number is K915530.

When did NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE receive FDA 510(k) clearance?

NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE received FDA 510(k) clearance on 1992-08-17, under 510(k) number K915530.

Who is the listed applicant for NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE?

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(R) DISPOSABLE NONWOVEN SPONGES, STERILE?

The FDA product code for NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE is HAX.

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Related Devices (Code: HAX)

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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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