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 |