The following data is part of a premarket notification filed by Medafor, Inc. with the FDA for Hemaderm Cotaining Hemadex Clotting Beads.
| Device ID | K021678 |
| 510k Number | K021678 |
| Device Name: | HEMADERM COTAINING HEMADEX CLOTTING BEADS |
| Classification | Dressing, Wound, Drug |
| 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 | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-21 |
| Decision Date | 2002-07-12 |
| Summary: | summary |