The following data is part of a premarket notification filed by Scican with the FDA for Sterimaster Autoclave.
Device ID | K944036 |
510k Number | K944036 |
Device Name: | STERIMASTER AUTOCLAVE |
Classification | Sterilizer, Steam |
Applicant | SCICAN 1440 DON MILLS RD. Toronto, Ontario, CA M3b 3p9 |
Contact | Neil Mcphail |
Correspondent | Neil Mcphail SCICAN 1440 DON MILLS RD. Toronto, Ontario, CA M3b 3p9 |
Product Code | FLE |
CFR Regulation Number | 880.6880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-08-18 |
Decision Date | 1996-10-02 |
Summary: | summary |