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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K953015
Device Name SAFESKIN SUPRA
Applicant
Safeskin Corp.
6815 Flanders Dr.
San Diego,  CA  92121
Applicant Contact WAVA TRUSCOTT
Correspondent
Safeskin Corp.
6815 Flanders Dr.
San Diego,  CA  92121
Correspondent Contact WAVA TRUSCOTT
Regulation Number878.4460
Classification Product Code
KGO  
Date Received06/29/1995
Decision Date 08/28/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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