The following data is part of a premarket notification filed by Scican Ltd. with the FDA for Salus - Hygiene Instrument Reprocessing Container.
Device ID | K172292 |
510k Number | K172292 |
Device Name: | SALUS - Hygiene Instrument Reprocessing Container |
Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
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 | KCT |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-07-31 |
Decision Date | 2017-11-24 |