The following data is part of a premarket notification filed by Biocore with the FDA for Skintemp, Modification.
| Device ID | K925545 |
| 510k Number | K925545 |
| Device Name: | SKINTEMP, MODIFICATION |
| Classification | Dressing, Wound, Collagen |
| Applicant | BIOCORE 7420 FALCON ST. Topeka, KS 66610 |
| Contact | Manoj K Jain |
| Correspondent | Manoj K Jain BIOCORE 7420 FALCON ST. Topeka, KS 66610 |
| Product Code | KGN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-15 |
| Decision Date | 1993-02-23 |