DENTAL, MEDICAL INSTRUMENT CASES & CASSETTE
Device Facts
| Record ID | K962545 |
|---|---|
| Device Name | DENTAL, MEDICAL INSTRUMENT CASES & CASSETTE |
| Applicant | Sterilization Cassette Systems, Inc. |
| Product Code | KCT · General Hospital |
| Decision Date | Mar 7, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6850 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.
