FDA 510(k)

EXAM GOWN

K-Number: K770476 · 1977-05-06

Decision Date1977-05-06

Product CodeFME

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

EXAM GOWN is the device name listed in this FDA 510(k) record. The listed applicant is General Medical Co.. It received FDA 510(k) clearance on 1977-05-06 under 510(k) number K770476. The device is classified under product code FME. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXAM GOWN?

EXAM GOWN is a medical device that received FDA 510(k) clearance on 1977-05-06. The listed applicant is General Medical Co.. The 510(k) number is K770476.

When did EXAM GOWN receive FDA 510(k) clearance?

EXAM GOWN received FDA 510(k) clearance on 1977-05-06, under 510(k) number K770476.

Who is the listed applicant for EXAM GOWN?

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

What is the FDA product code for EXAM GOWN?

The FDA product code for EXAM GOWN is FME.

Other records listing General Medical 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.

K926269PROCEDURE KIT K912975OPERAND LUBRICATING JELLY K912132OPERAND LUBRICATING JELLY K903669GENESIS INSUFFLATING CATHETER K900110OPERAND* LUBRICATING JELLY K853635SUBDERM TM

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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.