The following data is part of a premarket notification filed by Inhalation Plastics with the FDA for Anesthesia Breathing Circuit.
Device ID | K900594 |
510k Number | K900594 |
Device Name: | ANESTHESIA BREATHING CIRCUIT |
Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
Applicant | INHALATION PLASTICS 7790 N. MERRIMAC Chicago, IL 60648 |
Contact | Jim Lekkas |
Correspondent | Jim Lekkas INHALATION PLASTICS 7790 N. MERRIMAC Chicago, IL 60648 |
Product Code | CAI |
CFR Regulation Number | 868.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-02-07 |
Decision Date | 1990-03-15 |