The following data is part of a premarket notification filed by Hemcon, Inc. with the FDA for Hemcon Dental Dressing, 1 Dressing, 4 Dressing, 1 Dressing, Box Of 12, 4 Dressing, Box Of 12.
| Device ID | K060363 |
| 510k Number | K060363 |
| Device Name: | HEMCON DENTAL DRESSING, 1 DRESSING, 4 DRESSING, 1 DRESSING, BOX OF 12, 4 DRESSING, BOX OF 12 |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | HEMCON, INC. 10575 SW CASCADE BLVD. SUITE 130 Portland, OR 97223 |
| Contact | Kevin Hawkins |
| Correspondent | Kevin Hawkins HEMCON, INC. 10575 SW CASCADE BLVD. SUITE 130 Portland, OR 97223 |
| Product Code | MGQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-13 |
| Decision Date | 2006-07-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20870053001118 | K060363 | 000 |
| 20870053001033 | K060363 | 000 |