The following data is part of a premarket notification filed by Military Engineering, Inc. with the FDA for Mallet, Bone Surgery, Stainless Steel, 2lb..
| Device ID | K871195 |
| 510k Number | K871195 |
| Device Name: | MALLET, BONE SURGERY, STAINLESS STEEL, 2LB. |
| Classification | Mallet |
| 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 | HXL |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-24 |
| Decision Date | 1987-04-06 |