The following data is part of a premarket notification filed by Cleveland Tubing, Inc. with the FDA for Cleveland Tubing, Inc. Ventilator Hoses.
Device ID | K932119 |
510k Number | K932119 |
Device Name: | CLEVELAND TUBING, INC. VENTILATOR HOSES |
Classification | Set, Tubing And Support, Ventilator (w Harness) |
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 | BZO |
CFR Regulation Number | 868.5975 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-03 |
Decision Date | 1993-06-23 |