The following data is part of a premarket notification filed by Hemcon Medical Technologies, Inc. with the FDA for Hemcon Bandage Pro, Hemcon Patch Pro, Hemcon Strip Pro, Hemcon Strip First Aid Pro, Chitoflex Pro.
| Device ID | K150916 |
| 510k Number | K150916 |
| Device Name: | HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PRO |
| Classification | Dressing, Wound, Drug |
| Applicant | HemCon Medical Technologies, Inc. 720 SW Washington Street, Suite 200 Portland, OR 97225 |
| Contact | Jody Oyama |
| Correspondent | Jody Oyama HemCon Medical Technologies, Inc. 720 SW Washington Street, Suite 200 Portland, OR 97225 |
| 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 | 2015-04-06 |
| Decision Date | 2015-11-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00870053000322 | K150916 | 000 |
| 50870053000358 | K150916 | 000 |
| 20870053000043 | K150916 | 000 |
| 00870053000360 | K150916 | 000 |
| 20870053000333 | K150916 | 000 |
| 20870053000418 | K150916 | 000 |
| 20870053000401 | K150916 | 000 |