The following data is part of a premarket notification filed by Military Engineering, Inc. with the FDA for Bone Pin Cutter 18.
Device ID | K873715 |
510k Number | K873715 |
Device Name: | BONE PIN CUTTER 18 |
Classification | Cutter, Wire |
Applicant | MILITARY ENGINEERING, INC. P.O. BOX J 2135 WESTERN AVENUE Plymouth, IN 46563 |
Contact | Jeffrey L Yoder |
Correspondent | Jeffrey L Yoder MILITARY ENGINEERING, INC. P.O. BOX J 2135 WESTERN AVENUE Plymouth, IN 46563 |
Product Code | HXZ |
CFR Regulation Number | 888.4540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-15 |
Decision Date | 1987-10-28 |