The following data is part of a premarket notification filed by Chitogen, Inc. with the FDA for Softseal-c.
| Device ID | K112864 |
| 510k Number | K112864 |
| Device Name: | SOFTSEAL-C |
| Classification | Dressing, Wound, Drug |
| Applicant | CHITOGEN, INC. 7255 OHMS LANE Minneapolis, MN 55439 |
| Contact | James F Drake |
| Correspondent | James F Drake CHITOGEN, INC. 7255 OHMS LANE Minneapolis, MN 55439 |
| 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 | 2011-09-30 |
| Decision Date | 2012-08-02 |
| Summary: | summary |