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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 K894073
Device Name INAMED PRO-TEC SILICONE SURGICAL GLOVES
Applicant
Inamed Development Co.
1035 A. Cindy Ln.
Carpinteria,  CA  93013
Applicant Contact ELLEN DUKE
Correspondent
Inamed Development Co.
1035 A. Cindy Ln.
Carpinteria,  CA  93013
Correspondent Contact ELLEN DUKE
Regulation Number878.4460
Classification Product Code
KGO  
Date Received06/08/1989
Decision Date 09/18/1989
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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