BLAINE SCARCARE PATCH

Elastomer, Silicone, For Scar Management

BLAINE LABS, INC.

The following data is part of a premarket notification filed by Blaine Labs, Inc. with the FDA for Blaine Scarcare Patch.

Pre-market Notification Details

Device IDK001608
510k NumberK001608
Device Name:BLAINE SCARCARE PATCH
ClassificationElastomer, Silicone, For Scar Management
Applicant BLAINE LABS, INC. 9624 SOUTH JOHN ST. UNIT 101 Santa Fe Springs,  CA  90679
ContactRobert Blaine
CorrespondentRobert Blaine
BLAINE LABS, INC. 9624 SOUTH JOHN ST. UNIT 101 Santa Fe Springs,  CA  90679
Product CodeMDA  
CFR Regulation Number878.4025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-05-24
Decision Date2000-07-25

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