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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Ultraviolet, Dermatological
510(k) Number K851858
Device Name FOLD AWAY HUT
Applicant
TANNHUT
ROUTE 50
SARATOGA SPRINGS,  NY  12866
Applicant Contact JANICE SHIVETTS
Correspondent
TANNHUT
ROUTE 50
SARATOGA SPRINGS,  NY  12866
Correspondent Contact JANICE SHIVETTS
Regulation Number878.4630
Classification Product Code
FTC  
Date Received04/26/1985
Decision Date 05/14/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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