The following data is part of a premarket notification filed by Inlet Medical, Inc. with the FDA for Inlet Irrigation/aspiration Valve And Probes.
| Device ID | K923528 |
| 510k Number | K923528 |
| Device Name: | INLET IRRIGATION/ASPIRATION VALVE AND PROBES |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | INLET MEDICAL, INC. 6470 RIVERVIEW TERRACE Minneapolis, MN 55432 |
| Contact | Constance G Bundy |
| Correspondent | Constance G Bundy INLET MEDICAL, INC. 6470 RIVERVIEW TERRACE Minneapolis, MN 55432 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-16 |
| Decision Date | 1993-01-12 |