The following data is part of a premarket notification filed by Hemcon Medical Technologies, Inc. with the FDA for Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-surgical Dressing.
| Device ID | K080818 |
| 510k Number | K080818 |
| Device Name: | HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | HEMCON MEDICAL TECHNOLOGIES, INC. 10575 SW CASCADE AVENUE SUITE 130 Portland, OR 97223 -4363 |
| Contact | Kevin Hawkins |
| Correspondent | Kevin Hawkins HEMCON MEDICAL TECHNOLOGIES, 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 | No |
| Date Received | 2008-03-24 |
| Decision Date | 2008-05-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20870053001859 | K080818 | 000 |
| 20870053001293 | K080818 | 000 |
| 20870053001019 | K080818 | 000 |
| 20870053001125 | K080818 | 000 |
| 00870053001268 | K080818 | 000 |