The following data is part of a premarket notification filed by Military Engineering, Inc. with the FDA for Explorer-dental Prober.
Device ID | K874335 |
510k Number | K874335 |
Device Name: | EXPLORER-DENTAL PROBER |
Classification | Burnisher, Operative |
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 | EKJ |
CFR Regulation Number | 872.4565 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-10-22 |
Decision Date | 1987-12-29 |