The following data is part of a premarket notification filed by Medafor, Inc. with the FDA for Instaclot For Otc Use, Traumasstat For Prescription Use.
| Device ID | K013225 |
| 510k Number | K013225 |
| Device Name: | INSTACLOT FOR OTC USE, TRAUMASSTAT FOR PRESCRIPTION USE |
| Classification | Bandage, Liquid |
| Applicant | MEDAFOR, INC. 5201 EAST RIVER ROAD, # 312 Minneapolis, MN 55421 -1035 |
| Contact | Philip B Jarvi |
| Correspondent | Philip B Jarvi MEDAFOR, INC. 5201 EAST RIVER ROAD, # 312 Minneapolis, MN 55421 -1035 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-27 |
| Decision Date | 2001-12-26 |
| Summary: | summary |