The following data is part of a premarket notification filed by Chitogen, Inc. with the FDA for Softseal-stf.
| Device ID | K090100 |
| 510k Number | K090100 |
| Device Name: | SOFTSEAL-STF |
| Classification | Dressing, Wound, Drug |
| Applicant | CHITOGEN, INC. 7255 OHMS LANE Minneapolis, MN 55439 |
| Contact | Janna Bereuter |
| Correspondent | Janna Bereuter 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 | 2009-01-15 |
| Decision Date | 2009-03-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10862499000254 | K090100 | 000 |
| 00862499000202 | K090100 | 000 |
| 10862499000261 | K090100 | 000 |