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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 K942339
Device Name SKIN NEUVEAU SCAR TREATMENT
Applicant
Puritas Health Care, Inc.
219 Kent Rd.,
Suite 20
New Milford,  CT  06776
Applicant Contact THOMAS P DI MAIO
Correspondent
Puritas Health Care, Inc.
219 Kent Rd.,
Suite 20
New Milford,  CT  06776
Correspondent Contact THOMAS P DI MAIO
Regulation Number878.4025
Classification Product Code
MDA  
Date Received05/16/1994
Decision Date 11/28/1994
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
Predetermined Change
Control Plan Authorized		 No
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