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FDA 510(k)

SPEEDWRAP, DYNAWRAP, DYNAPLAST TAPE

K-Number: K903823 · 1991-01-16

ApplicantSmith and Nephew Donjoy, Inc.
Decision Date1991-01-16
Product CodeKGX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SPEEDWRAP, DYNAWRAP, DYNAPLAST TAPE is the device name listed in this FDA 510(k) record. The listed applicant is Smith and Nephew Donjoy, Inc.. It received FDA 510(k) clearance on 1991-01-16 under 510(k) number K903823. The device is classified under product code KGX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPEEDWRAP, DYNAWRAP, DYNAPLAST TAPE?

SPEEDWRAP, DYNAWRAP, DYNAPLAST TAPE is a medical device that received FDA 510(k) clearance on 1991-01-16. The listed applicant is Smith and Nephew Donjoy, Inc.. The 510(k) number is K903823.

When did SPEEDWRAP, DYNAWRAP, DYNAPLAST TAPE receive FDA 510(k) clearance?

SPEEDWRAP, DYNAWRAP, DYNAPLAST TAPE received FDA 510(k) clearance on 1991-01-16, under 510(k) number K903823.

Who is the listed applicant for SPEEDWRAP, DYNAWRAP, DYNAPLAST TAPE?

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

What is the FDA product code for SPEEDWRAP, DYNAWRAP, DYNAPLAST TAPE?

The FDA product code for SPEEDWRAP, DYNAWRAP, DYNAPLAST TAPE is KGX.

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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.

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