The following data is part of a premarket notification filed by Military Engineering, Inc. with the FDA for Oec Design Orthopedic Cast Heel.
Device ID | K864092 |
510k Number | K864092 |
Device Name: | OEC DESIGN ORTHOPEDIC CAST HEEL |
Classification | Component, Cast |
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 | LGF |
CFR Regulation Number | 888.5940 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-10-21 |
Decision Date | 1986-12-16 |