The following data is part of a premarket notification filed by Oticon Medical Ab with the FDA for Sterilization Cassette.
| Device ID | K141616 |
| 510k Number | K141616 |
| Device Name: | STERILIZATION CASSETTE |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | OTICON MEDICAL AB EKONOMIVAGEN 2 Askim, SE Se-436 33 |
| Contact | Carol A Wessling |
| Correspondent | Carol A Wessling OTICON MEDICAL AB EKONOMIVAGEN 2 Askim, SE Se-436 33 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-16 |
| Decision Date | 2014-09-23 |
| Summary: | summary |