The following data is part of a premarket notification filed by Scican with the FDA for Statim 5000 Cassette Autoclave.
| Device ID | K983679 |
| 510k Number | K983679 |
| Device Name: | STATIM 5000 CASSETTE AUTOCLAVE |
| Classification | Sterilizer, Steam |
| Applicant | SCICAN 1440 DON MILLS RD. Toronto, Ontario, CA M3b 3p9 |
| Contact | Brenda Murphy |
| Correspondent | Brenda Murphy SCICAN 1440 DON MILLS RD. Toronto, Ontario, CA M3b 3p9 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-20 |
| Decision Date | 1999-01-04 |