The following data is part of a premarket notification filed by Medicomp, Inc. with the FDA for Gas/pres Monit Endot Tub Conn/adop W/ & W/o Tub.
Device ID | K852632 |
510k Number | K852632 |
Device Name: | GAS/PRES MONIT ENDOT TUB CONN/ADOP W/ & W/O TUB |
Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
Applicant | MEDICOMP, INC. 411 FREEMONT ST. Anoka, MN 55303 |
Contact | Duncan G Johnson |
Correspondent | Duncan G Johnson MEDICOMP, INC. 411 FREEMONT ST. Anoka, MN 55303 |
Product Code | CAI |
CFR Regulation Number | 868.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-06-20 |
Decision Date | 1986-01-03 |