The following data is part of a premarket notification filed by B & B Medical Technologies, Inc. with the FDA for Sure-lock Ventilator Tubing Holder.
| Device ID | K944324 |
| 510k Number | K944324 |
| Device Name: | SURE-LOCK VENTILATOR TUBING HOLDER |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | B & B MEDICAL TECHNOLOGIES, INC. 3569 RECYCLE RD., SUITE 16 Rancho Cordova, CA 95670 |
| Contact | John D Calebaugh |
| Correspondent | John D Calebaugh B & B MEDICAL TECHNOLOGIES, INC. 3569 RECYCLE RD., SUITE 16 Rancho Cordova, CA 95670 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-02 |
| Decision Date | 1994-11-04 |