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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 K001608
Device Name BLAINE SCARCARE PATCH
Applicant
Blaine Labs, Inc.
9624 S. John St.
Unit 101
Santa Fe Springs,  CA  90679
Applicant Contact ROBERT BLAINE
Correspondent
Blaine Labs, Inc.
9624 S. John St.
Unit 101
Santa Fe Springs,  CA  90679
Correspondent Contact ROBERT BLAINE
Regulation Number878.4025
Classification Product Code
MDA  
Date Received05/24/2000
Decision Date 07/25/2000
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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