The following data is part of a premarket notification filed by Southmedic, Inc. with the FDA for Vapofil.
Device ID | K861839 |
510k Number | K861839 |
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 | 1986-05-13 |
Decision Date | 1986-05-21 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VAPOFIL 73609154 1454081 Dead/Cancelled |
SOUTHMEDIC INCORPORATED 1986-07-14 |