The following data is part of a premarket notification filed by Advanced Bio-technologies, Inc. with the FDA for Kelo-cote Spray.
| Device ID | K053481 |
| 510k Number | K053481 |
| Device Name: | KELO-COTE SPRAY |
| Classification | Elastomer, Silicone, For Scar Management |
| Applicant | ADVANCED BIO-TECHNOLOGIES, INC. P.O. BOX 3515 Redmond, WA 98073 -3515 |
| Contact | Steven Chernoff |
| Correspondent | Steven Chernoff ADVANCED BIO-TECHNOLOGIES, INC. P.O. BOX 3515 Redmond, WA 98073 -3515 |
| Product Code | MDA |
| CFR Regulation Number | 878.4025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-14 |
| Decision Date | 2006-04-14 |
| Summary: | summary |