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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Elastomer, Silicone, For Scar Management
510(k) Number K974380
Device Name REJUVENESS
Applicant
Rejuveness Pharamceuticals, Inc.
100 Saratoga Village Blvd.
Ballston Spa,  NY  12020
Applicant Contact RICHARD A PICCOLO
Correspondent
Rejuveness Pharamceuticals, Inc.
100 Saratoga Village Blvd.
Ballston Spa,  NY  12020
Correspondent Contact RICHARD A PICCOLO
Regulation Number878.4025
Classification Product Code
MDA  
Date Received10/21/1997
Decision Date 04/03/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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