The following data is part of a premarket notification filed by Regulatory Consultants To The Medical Device Indus with the FDA for Articulated, Laparoscopic, And Side-viewing T-probes.
| Device ID | K935157 |
| 510k Number | K935157 |
| Device Name: | ARTICULATED, LAPAROSCOPIC, AND SIDE-VIEWING T-PROBES |
| Classification | Changer, Radiographic Film/cassette |
| Applicant | REGULATORY CONSULTANTS TO THE MEDICAL DEVICE INDUS 9712 S. ALTAMONT DR. Sandy, UT 84092 |
| Contact | William E Mckay |
| Correspondent | William E Mckay REGULATORY CONSULTANTS TO THE MEDICAL DEVICE INDUS 9712 S. ALTAMONT DR. Sandy, UT 84092 |
| Product Code | KPX |
| CFR Regulation Number | 892.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-28 |
| Decision Date | 1994-08-09 |