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 |