The following data is part of a premarket notification filed by Extracorporeal Medical Specialities, Inc. with the FDA for Model Gv-10 Lanz Pressure-valve.
| Device ID | K791045 |
| 510k Number | K791045 |
| Device Name: | MODEL GV-10 LANZ PRESSURE-VALVE |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | EXTRACORPOREAL MEDICAL SPECIALITIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-06-05 |
| Decision Date | 1979-06-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60884522007448 | K791045 | 000 |
| 60884522007431 | K791045 | 000 |
| 60884522007424 | K791045 | 000 |
| 40884522007413 | K791045 | 000 |
| 60884522007400 | K791045 | 000 |
| 60884522007394 | K791045 | 000 |
| 60884522007387 | K791045 | 000 |
| 40884522007376 | K791045 | 000 |
| 60884522007363 | K791045 | 000 |