The following data is part of a premarket notification filed by Imperial Surgical Ltd. with the FDA for Imperial Surgical Ltd. Blankey And Solution Warning Cabinets.
Device ID | K112702 |
510k Number | K112702 |
Device Name: | IMPERIAL SURGICAL LTD. BLANKEY AND SOLUTION WARNING CABINETS |
Classification | Warmer, Thermal, Infusion Fluid |
Applicant | IMPERIAL SURGICAL LTD. 4 INNOVATION DRIVE Dundas, CA L9h 7p3 |
Contact | Kathryn Ronalds |
Correspondent | Kathryn Ronalds IMPERIAL SURGICAL LTD. 4 INNOVATION DRIVE Dundas, CA L9h 7p3 |
Product Code | LGZ |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-09-16 |
Decision Date | 2012-03-29 |
Summary: | summary |