The following data is part of a premarket notification filed by Scican Ltd. with the FDA for Statclave G4 Chamber Autoclave.
| Device ID | K192910 |
| 510k Number | K192910 |
| Device Name: | STATClave G4 Chamber Autoclave |
| Classification | Sterilizer, Steam |
| Applicant | SciCan Ltd. 1440 Don Mills Road Toronto, CA M3b 3p9 |
| Contact | Teresa Boyce |
| Correspondent | Teresa Boyce SciCan Ltd. 1440 Don Mills Road Toronto, CA M3b 3p9 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-15 |
| Decision Date | 2020-06-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07540196001793 | K192910 | 000 |