The following data is part of a premarket notification filed by Coltene/whaledent Inc. with the FDA for Biosonic Uc-70 Sterilizable Instrument Cassette.
| Device ID | K993255 |
| 510k Number | K993255 |
| Device Name: | BIOSONIC UC-70 STERILIZABLE INSTRUMENT CASSETTE |
| Classification | Wrap, Sterilization |
| Applicant | COLTENE/WHALEDENT INC. 750 CORPORATE DR. Mahwah, NJ 07430 -2009 |
| Contact | H.j. Vogelstein |
| Correspondent | H.j. Vogelstein COLTENE/WHALEDENT INC. 750 CORPORATE DR. Mahwah, NJ 07430 -2009 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-28 |
| Decision Date | 1999-12-06 |