FDA 510(k)

THEATRE GOWNS

K-Number: K872758 · 1987-07-31

Decision Date1987-07-31

Product CodeFYA

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

THEATRE GOWNS is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 1987-07-31 under 510(k) number K872758. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THEATRE GOWNS?

THEATRE GOWNS is a medical device that received FDA 510(k) clearance on 1987-07-31. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K872758.

When did THEATRE GOWNS receive FDA 510(k) clearance?

THEATRE GOWNS received FDA 510(k) clearance on 1987-07-31, under 510(k) number K872758.

Who is the listed applicant for THEATRE GOWNS?

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

What is the FDA product code for THEATRE GOWNS?

The FDA product code for THEATRE GOWNS is FYA.

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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.