The following data is part of a premarket notification filed by Hemcon, Inc. with the FDA for Hemcon Chitoflex-surgical Dressing.
| Device ID | K071519 |
| 510k Number | K071519 |
| Device Name: | HEMCON CHITOFLEX-SURGICAL DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | HEMCON, INC. 10575 SW CASCADE AVENUE SUITE 130 Portland, OR 97223 -4363 |
| Contact | Kevin Hawkins |
| Correspondent | Kevin Hawkins HEMCON, INC. 10575 SW CASCADE AVENUE SUITE 130 Portland, OR 97223 -4363 |
| 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 | 2007-06-04 |
| Decision Date | 2007-08-06 |
| Summary: | summary |