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FDA 510(k)

GONAD SHIELD

K-Number: K790639 · 1979-04-23

ApplicantThe Mochlett Laboratories, Inc.
Decision Date1979-04-23
Product CodeKPY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GONAD SHIELD is the device name listed in this FDA 510(k) record. The listed applicant is The Mochlett Laboratories, Inc.. It received FDA 510(k) clearance on 1979-04-23 under 510(k) number K790639. The device is classified under product code KPY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GONAD SHIELD?

GONAD SHIELD is a medical device that received FDA 510(k) clearance on 1979-04-23. The listed applicant is The Mochlett Laboratories, Inc.. The 510(k) number is K790639.

When did GONAD SHIELD receive FDA 510(k) clearance?

GONAD SHIELD received FDA 510(k) clearance on 1979-04-23, under 510(k) number K790639.

Who is the listed applicant for GONAD SHIELD?

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

What is the FDA product code for GONAD SHIELD?

The FDA product code for GONAD SHIELD is KPY.

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Related Devices (Code: KPY)

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.

K110900DISPOSABLE THYROID COLLARBloxr CorporationK962622INTRA-ORAL THERMOPLASTIC SHIELDMedtec, Inc.K954456THERMOPLASTIC SHIELDMedtec, Inc.K954146UTK-DTE AUTILARY SHIELDMallinckrodt MedicalK953610AUKULYTEAukland Medical Plastics, Inc.K9510042001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4)Kenex , Ltd.

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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