The following data is part of a premarket notification filed by Scican with the FDA for Statim Cassett Autoclave, Modification.
| Device ID | K915054 |
| 510k Number | K915054 |
| Device Name: | STATIM CASSETT AUTOCLAVE, MODIFICATION |
| Classification | Sterilizer, Steam |
| Applicant | SCICAN 260 YORKLAND BLVD. Toronto, Ontario, CA M2j 1r7 |
| Contact | Duncan Newman |
| Correspondent | Duncan Newman SCICAN 260 YORKLAND BLVD. Toronto, Ontario, CA M2j 1r7 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-04 |
| Decision Date | 1992-08-04 |