The following data is part of a premarket notification filed by Hanson Medical, Inc. with the FDA for Kelocote Scar Gel And Kelocote Laser Gel.
| Device ID | K973572 |
| 510k Number | K973572 |
| Device Name: | KELOCOTE SCAR GEL AND KELOCOTE LASER GEL |
| Classification | Elastomer, Silicone, For Scar Management |
| Applicant | HANSON MEDICAL, INC. P.O. BOX 1160 Kingston, WA 98346 |
| Contact | Erik Hanson |
| Correspondent | Erik Hanson HANSON MEDICAL, INC. P.O. BOX 1160 Kingston, WA 98346 |
| Product Code | MDA |
| CFR Regulation Number | 878.4025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-19 |
| Decision Date | 1997-10-21 |
| Summary: | summary |