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FDA 510(k)

SOLOSITE GEL CONFORMABLE DRESSING

K-Number: K981150 · 1998-06-22

ApplicantSmith & Nephew, Inc.
Decision Date1998-06-22
Product CodeMGQ
DecisionSubstantially Equivalent

Device Summary

SOLOSITE GEL CONFORMABLE DRESSING 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 1998-06-22 under 510(k) number K981150. The device is classified under product code MGQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOLOSITE GEL CONFORMABLE DRESSING?

SOLOSITE GEL CONFORMABLE DRESSING is a medical device that received FDA 510(k) clearance on 1998-06-22. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K981150.

When did SOLOSITE GEL CONFORMABLE DRESSING receive FDA 510(k) clearance?

SOLOSITE GEL CONFORMABLE DRESSING received FDA 510(k) clearance on 1998-06-22, under 510(k) number K981150.

Who is the listed applicant for SOLOSITE GEL CONFORMABLE DRESSING?

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 SOLOSITE GEL CONFORMABLE DRESSING?

The FDA product code for SOLOSITE GEL CONFORMABLE DRESSING is MGQ.

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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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