The following data is part of a premarket notification filed by Military Engineering, Inc. with the FDA for Elevator, Cobb Spinal.
Device ID | K870591 |
510k Number | K870591 |
Device Name: | ELEVATOR, COBB SPINAL |
Classification | Elevator, Surgical, General & Plastic Surgery |
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 | GEG |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-02-10 |
Decision Date | 1987-02-26 |