The following data is part of a premarket notification filed by American Russian Medical Services, Inc. with the FDA for Microsurgical Instruments.
Device ID | K932169 |
510k Number | K932169 |
Device Name: | MICROSURGICAL INSTRUMENTS |
Classification | Instrument, Microsurgical |
Applicant | AMERICAN RUSSIAN MEDICAL SERVICES, INC. 770 LAKELAND DR. #235 Jackson, MS 39216 |
Contact | Lon Alexander |
Correspondent | Lon Alexander AMERICAN RUSSIAN MEDICAL SERVICES, INC. 770 LAKELAND DR. #235 Jackson, MS 39216 |
Product Code | GZX |
CFR Regulation Number | 882.4525 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-05 |
Decision Date | 1993-07-20 |