The following data is part of a premarket notification filed by Micro-aire Surgical Instruments, Inc. with the FDA for Steinmann(threaded/calibrated),knowles&hogie Pins.
Device ID | K863734 |
510k Number | K863734 |
Device Name: | STEINMANN(THREADED/CALIBRATED),KNOWLES&HOGIE PINS |
Classification | Pin, Fixation, Smooth |
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 | HTY |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-09-23 |
Decision Date | 1986-10-20 |