The following data is part of a premarket notification filed by Hemcon, Inc. with the FDA for Hemcon Bandage Otc; Hemcon Cath/aid.
| Device ID | K030946 |
| 510k Number | K030946 |
| Device Name: | HEMCON BANDAGE OTC; HEMCON CATH/AID |
| Classification | Dressing, Wound, Drug |
| Applicant | HEMCON, INC. 10575 SW CASCADE AVE. SUITE 130 Tigard, OR 97223 |
| Contact | James F Hensel |
| Correspondent | James F Hensel HEMCON, INC. 10575 SW CASCADE AVE. SUITE 130 Tigard, OR 97223 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2003-03-26 |
| Decision Date | 2003-06-19 |
| Summary: | summary |