The following data is part of a premarket notification filed by Military Engineering, Inc. with the FDA for Driver-bender-extractor, Bone Pin.
Device ID | K870668 |
510k Number | K870668 |
Device Name: | DRIVER-BENDER-EXTRACTOR, BONE PIN |
Classification | Bender |
Applicant | MILITARY ENGINEERING, INC. P.O. BOX J 2135 WESTERN AVENUE Plymouth, IN 46563 |
Contact | Lee L Heyde |
Correspondent | Lee L Heyde MILITARY ENGINEERING, INC. P.O. BOX J 2135 WESTERN AVENUE Plymouth, IN 46563 |
Product Code | HXW |
CFR Regulation Number | 888.4540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-02-19 |
Decision Date | 1987-03-09 |