The following data is part of a premarket notification filed by Micro-aire Surgical Instruments, Inc. with the FDA for 1.1 Screwdrivers.
Device ID | K872490 |
510k Number | K872490 |
Device Name: | 1.1 SCREWDRIVERS |
Classification | Screwdriver, Surgical |
Applicant | MICRO-AIRE SURGICAL INSTRUMENTS, INC. 505 FOURTH ST. San Fernando, CA 91340 |
Contact | Siddharth Desai |
Correspondent | Siddharth Desai MICRO-AIRE SURGICAL INSTRUMENTS, INC. 505 FOURTH ST. San Fernando, CA 91340 |
Product Code | LRZ |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-06-23 |
Decision Date | 1987-07-23 |