The following data is part of a premarket notification filed by Andronic Devices, Ltd. with the FDA for Arthrobot(tm) 75 (190 Cm) General Purpose Drape.
Device ID | K911520 |
510k Number | K911520 |
Device Name: | ARTHROBOT(TM) 75 (190 CM) GENERAL PURPOSE DRAPE |
Classification | Drape, Surgical |
Applicant | ANDRONIC DEVICES, LTD. 13120 VANIER PL SUITE 140 Richmond,b.c. V6v-2j2, CA |
Contact | Michael Clhan |
Correspondent | Michael Clhan ANDRONIC DEVICES, LTD. 13120 VANIER PL SUITE 140 Richmond,b.c. V6v-2j2, CA |
Product Code | KKX |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-04-04 |
Decision Date | 1991-08-02 |