The following data is part of a premarket notification filed by Cleveland Tubing, Inc. with the FDA for Cleveland Tubing, Inc. Expandable/collapsiblemedical Tubing.
| Device ID | K945314 |
| 510k Number | K945314 |
| Device Name: | CLEVELAND TUBING, INC. EXPANDABLE/COLLAPSIBLEMEDICAL TUBING |
| Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
| Applicant | CLEVELAND TUBING, INC. 1675 HARDEMAN LN. P.O. BOX 2698 Cleveland, TN 37320 |
| Contact | Daryl L Miller |
| Correspondent | Daryl L Miller 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 | 1994-11-01 |
| Decision Date | 1994-11-18 |