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U.S. Department of Health and Human Services

510(k) Premarket Notification

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510(k) Number K920240
Device Name SOLUMBRA SUN PROTECTIVE CLOTHING
Applicant
Wetmore Assoc., Inc.
310 W. Prospect St.
Seattle,  WA  98119
Applicant Contact HUGHES
Correspondent
Wetmore Assoc., Inc.
310 W. Prospect St.
Seattle,  WA  98119
Correspondent Contact HUGHES
Classification Product Code
MIW
Date Received01/17/1992
Decision Date 05/13/1992
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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