The following data is part of a premarket notification filed by Military Engineering, Inc. with the FDA for Spatula, Dental, Cement.
Device ID | K871818 |
510k Number | K871818 |
Device Name: | SPATULA, DENTAL, CEMENT |
Classification | Handle, Instrument, Dental |
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 | EJB |
CFR Regulation Number | 872.4565 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-05-11 |
Decision Date | 1987-07-02 |