The following data is part of a premarket notification filed by Hemcon, Inc. with the FDA for Hemcon Bandage And Hemcon Bandage Otc.
| Device ID | K043050 |
| 510k Number | K043050 |
| Device Name: | HEMCON BANDAGE AND HEMCON BANDAGE OTC |
| Classification | Dressing, Wound, Drug |
| Applicant | HEMCON, INC. 10575 SW CASCADE BLVD. SUITE 130 Tigard, OR 97223 |
| Contact | John W Morgan |
| Correspondent | John W Morgan HEMCON, INC. 10575 SW CASCADE BLVD. SUITE 130 Tigard, OR 97223 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-04 |
| Decision Date | 2005-06-03 |
| Summary: | summary |