The following data is part of a premarket notification filed by Hemcon Medical Technologies, Inc. with the FDA for Chitogauze,2 In X 2 In,8 Ply, 4 In X 4 In 8 Ply, 4 In X 8 In, 8ply, 1 In X 4 In, 8ply, Chitogauze, Packaging Strip, 1/2.
| Device ID | K092357 |
| 510k Number | K092357 |
| Device Name: | CHITOGAUZE,2 IN X 2 IN,8 PLY, 4 IN X 4 IN 8 PLY, 4 IN X 8 IN, 8PLY, 1 IN X 4 IN, 8PLY, CHITOGAUZE, PACKAGING STRIP, 1/2 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-04 |
| Decision Date | 2009-08-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00870053001350 | K092357 | 000 |
| 00870053001367 | K092357 | 000 |
| 50870053000303 | K092357 | 000 |
| 50870053000297 | K092357 | 000 |