The following data is part of a premarket notification filed by Cleveland Tubing, Inc. with the FDA for Connectors And Airway Extensions.
Device ID | K940889 |
510k Number | K940889 |
Device Name: | CONNECTORS AND AIRWAY EXTENSIONS |
Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
Applicant | CLEVELAND TUBING, INC. 1675 HARDEMAN LN. P.O. BOX 2698 Cleveland, TN 37320 |
Contact | Robert Steinbarger |
Correspondent | Robert Steinbarger CLEVELAND TUBING, INC. 1675 HARDEMAN LN. P.O. BOX 2698 Cleveland, TN 37320 |
Product Code | CAI |
CFR Regulation Number | 868.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-02-25 |
Decision Date | 1994-11-10 |