The following data is part of a premarket notification filed by Southmedic, Inc. with the FDA for Funnel Adaptor.
Device ID | K923265 |
510k Number | K923265 |
Device Name: | FUNNEL ADAPTOR |
Classification | Vaporizer, Anesthesia, Non-heated |
Applicant | SOUTHMEDIC, INC. P.O. BOX 1365 Barrie, Ontario Canada, CA L4m 5r4 |
Contact | Paul E Dryden |
Correspondent | Paul E Dryden SOUTHMEDIC, INC. P.O. BOX 1365 Barrie, Ontario Canada, CA L4m 5r4 |
Product Code | CAD |
CFR Regulation Number | 868.5880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-02 |
Decision Date | 1993-03-18 |