The following data is part of a premarket notification filed by Advanced Bio-technologies, Inc. with the FDA for Kelo-cote Topical Gel.
| Device ID | K002488 |
| 510k Number | K002488 |
| Device Name: | KELO-COTE TOPICAL GEL |
| Classification | Elastomer, Silicone, For Scar Management |
| Applicant | ADVANCED BIO-TECHNOLOGIES, INC. 53 NEEDHAM DR. SUITE 5, CW4 8FB Cranage, Cheshire, GB Cw4 8fb |
| Contact | David Bryant |
| Correspondent | David Bryant ADVANCED BIO-TECHNOLOGIES, INC. 53 NEEDHAM DR. SUITE 5, CW4 8FB Cranage, Cheshire, GB Cw4 8fb |
| Product Code | MDA |
| CFR Regulation Number | 878.4025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-14 |
| Decision Date | 2001-01-05 |