The following data is part of a premarket notification filed by Boehringer Laboratories with the FDA for Regulator, Pressure, Cuff.
| Device ID | K760453 |
| 510k Number | K760453 |
| Device Name: | REGULATOR, PRESSURE, CUFF |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | BOEHRINGER LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-08-16 |
| Decision Date | 1976-09-13 |