The following data is part of a premarket notification filed by Military Engineering, Inc. with the FDA for Osteotome Set, Hoke, Straight, Set Of 5.
Device ID | K872092 |
510k Number | K872092 |
Device Name: | OSTEOTOME SET, HOKE, STRAIGHT, SET OF 5 |
Classification | Chisel (osteotome) |
Applicant | MILITARY ENGINEERING, INC. P.O. BOX J 2135 WESTERN AVENUE Plymouth, IN 46563 |
Contact | Robert W Francis |
Correspondent | Robert W Francis MILITARY ENGINEERING, INC. P.O. BOX J 2135 WESTERN AVENUE Plymouth, IN 46563 |
Product Code | KDG |
CFR Regulation Number | 878.4820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-06-01 |
Decision Date | 1987-06-23 |