FDA 510(k)

OPSITE SPECIALITY DRAPES

K-Number: K872757 · 1987-07-28

Decision Date1987-07-28

Product CodeKKX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

OPSITE SPECIALITY DRAPES 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 1987-07-28 under 510(k) number K872757. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPSITE SPECIALITY DRAPES?

OPSITE SPECIALITY DRAPES is a medical device that received FDA 510(k) clearance on 1987-07-28. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K872757.

When did OPSITE SPECIALITY DRAPES receive FDA 510(k) clearance?

OPSITE SPECIALITY DRAPES received FDA 510(k) clearance on 1987-07-28, under 510(k) number K872757.

Who is the listed applicant for OPSITE SPECIALITY DRAPES?

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 OPSITE SPECIALITY DRAPES?

The FDA product code for OPSITE SPECIALITY DRAPES is KKX.

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Other records listing Smith & Nephew, Inc. as applicant

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Related Devices (Code: KKX)

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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.