The following data is part of a premarket notification filed by Southmedic, Inc. with the FDA for Vapofil.
Device ID | K945993 |
510k Number | K945993 |
Device Name: | VAPOFIL |
Classification | Vaporizer, Anesthesia, Non-heated |
Applicant | SOUTHMEDIC, INC. P.O. BOX 1365 Barrie, Ontario Canada, CA L4m 5r4 |
Contact | Lee Mcdonald |
Correspondent | Lee Mcdonald 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 | 1994-11-18 |
Decision Date | 1995-02-22 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10620974001994 | K945993 | 000 |
10620974001895 | K945993 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VAPOFIL 73609154 1454081 Dead/Cancelled |
SOUTHMEDIC INCORPORATED 1986-07-14 |