The following data is part of a premarket notification filed by Andronic Devices, Ltd. with the FDA for Adept Instrument Positioning Accessory.
Device ID | K922626 |
510k Number | K922626 |
Device Name: | ADEPT INSTRUMENT POSITIONING ACCESSORY |
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 |