The following data is part of a premarket notification filed by Sterilization Cassette Systems, Inc. with the FDA for Dental, Medical Instrument Cases & Cassette.
| Device ID | K962545 |
| 510k Number | K962545 |
| Device Name: | DENTAL, MEDICAL INSTRUMENT CASES & CASSETTE |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | STERILIZATION CASSETTE SYSTEMS, INC. 435 E. MAIN, STE. A-6 Greenwood, IN 46143 |
| Contact | Stephen F Spencer |
| Correspondent | Stephen F Spencer STERILIZATION CASSETTE SYSTEMS, INC. 435 E. MAIN, STE. A-6 Greenwood, IN 46143 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-28 |
| Decision Date | 1997-03-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887482133293 | K962545 | 000 |
| 00887482133286 | K962545 | 000 |
| 00887482133279 | K962545 | 000 |
| 00887482057391 | K962545 | 000 |
| 00887482057384 | K962545 | 000 |
| 00887482057377 | K962545 | 000 |