The following data is part of a premarket notification filed by Blaine Labs, Inc. with the FDA for Blaine Scarcare Patch.
Device ID | K001608 |
510k Number | K001608 |
Device Name: | BLAINE SCARCARE PATCH |
Classification | Elastomer, Silicone, For Scar Management |
Applicant | BLAINE LABS, INC. 9624 SOUTH JOHN ST. UNIT 101 Santa Fe Springs, CA 90679 |
Contact | Robert Blaine |
Correspondent | Robert Blaine BLAINE LABS, INC. 9624 SOUTH JOHN ST. UNIT 101 Santa Fe Springs, CA 90679 |
Product Code | MDA |
CFR Regulation Number | 878.4025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-05-24 |
Decision Date | 2000-07-25 |