The following data is part of a premarket notification filed by Scican with the FDA for Statim Cassette Autoclave.
| Device ID | K910241 |
| 510k Number | K910241 |
| Device Name: | STATIM CASSETTE AUTOCLAVE |
| 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 | 1991-01-22 |
| Decision Date | 1991-05-03 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() STATIM CASSETTE AUTOCLAVE 74049416 1771289 Live/Registered |
LUX & ZWINGENBERGER LTD. 1990-04-16 |