The following data is part of a premarket notification filed by Scican Ltd. with the FDA for Statim 2000 G4 Cassette.
| Device ID | K112872 |
| 510k Number | K112872 |
| Device Name: | STATIM 2000 G4 CASSETTE |
| Classification | Sterilizer, Steam |
| Applicant | SCICAN LTD. 1440 DON MILLS RD. Toronto, Ontario, CA M3b 3p9 |
| Contact | Teresa Boyce |
| Correspondent | Teresa Boyce SCICAN LTD. 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 | 2011-09-30 |
| Decision Date | 2012-07-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07540196003193 | K112872 | 000 |
| 07540196003186 | K112872 | 000 |
| 07540196003179 | K112872 | 000 |