The following data is part of a premarket notification filed by Tei Biosciences Inc. with the FDA for Dressskin.
| Device ID | K023778 |
| 510k Number | K023778 |
| Device Name: | DRESSSKIN |
| Classification | Dressing, Wound, Collagen |
| Applicant | TEI BIOSCIENCES INC. 7 ELKINS ST. Boston, MA 02127 |
| Contact | Kenneth James |
| Correspondent | Kenneth James TEI BIOSCIENCES INC. 7 ELKINS ST. Boston, MA 02127 |
| Product Code | KGN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-12 |
| Decision Date | 2003-09-29 |
| Summary: | summary |