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FDA 510(k)

COVER GARD

K-Number: K790955 · 1979-06-20

ApplicantFem-Gard, Inc.
Decision Date1979-06-20
Product CodeFRK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

COVER GARD is the device name listed in this FDA 510(k) record. The listed applicant is Fem-Gard, Inc.. It received FDA 510(k) clearance on 1979-06-20 under 510(k) number K790955. The device is classified under product code FRK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COVER GARD?

COVER GARD is a medical device that received FDA 510(k) clearance on 1979-06-20. The listed applicant is Fem-Gard, Inc.. The 510(k) number is K790955.

When did COVER GARD receive FDA 510(k) clearance?

COVER GARD received FDA 510(k) clearance on 1979-06-20, under 510(k) number K790955.

Who is the listed applicant for COVER GARD?

The FDA 510(k) record lists Fem-Gard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COVER GARD?

The FDA product code for COVER GARD is FRK.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Fem-Gard, 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.

K790954HEEL GARD

Related Devices (Code: FRK)

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.

K896275JEDMED J-II CHAIRJedmed Instrument Co.K791016ULTICARE 2500 TREATMENT CHAIRAmerican Health Care Industries, Inc.K790954HEEL GARDFem-Gard, 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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