The following data is part of a premarket notification filed by Entellus Medical, Inc. with the FDA for Finess Endoscope Sterilization Tray.
| Device ID | K103213 |
| 510k Number | K103213 |
| Device Name: | FINESS ENDOSCOPE STERILIZATION TRAY |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | Entellus Medical, Inc. 6705 WEDGWOOD COURT NORTH Maple Grove, MN 55311 |
| Contact | Karen E Peterson |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-11-01 |
| Decision Date | 2011-02-02 |
| Summary: | summary |