The following data is part of a premarket notification filed by Andronic Devices, Ltd. with the FDA for Adept Endoscopic Positioner.
| Device ID | K922625 |
| 510k Number | K922625 |
| Device Name: | ADEPT ENDOSCOPIC POSITIONER |
| Classification | Retractor |
| Applicant | ANDRONIC DEVICES, LTD. 13120 VANIER PL SUITE 140 Richmond,b.c. V6v-2j2, CA |
| Contact | Robert Macneil |
| Correspondent | Robert Macneil ANDRONIC DEVICES, LTD. 13120 VANIER PL SUITE 140 Richmond,b.c. V6v-2j2, CA |
| Product Code | GAD |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-03 |
| Decision Date | 1992-10-19 |