FDA 510(k)

TENSOPLAST SKIN TRACTION KIT

K-Number: K820612 · 1982-03-31

Decision Date1982-03-31

Product CodeHST

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

TENSOPLAST SKIN TRACTION KIT 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 1982-03-31 under 510(k) number K820612. The device is classified under product code HST. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TENSOPLAST SKIN TRACTION KIT?

TENSOPLAST SKIN TRACTION KIT is a medical device that received FDA 510(k) clearance on 1982-03-31. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K820612.

When did TENSOPLAST SKIN TRACTION KIT receive FDA 510(k) clearance?

TENSOPLAST SKIN TRACTION KIT received FDA 510(k) clearance on 1982-03-31, under 510(k) number K820612.

Who is the listed applicant for TENSOPLAST SKIN TRACTION KIT?

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 TENSOPLAST SKIN TRACTION KIT?

The FDA product code for TENSOPLAST SKIN TRACTION KIT is HST.

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Related Devices (Code: HST)

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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.