The following data is part of a premarket notification filed by Applied Research Corp. with the FDA for Shea Footplate Microdrill.
| Device ID | K833875 |
| 510k Number | K833875 |
| Device Name: | SHEA FOOTPLATE MICRODRILL |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | APPLIED RESEARCH CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | ERL |
| CFR Regulation Number | 874.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-08 |
| Decision Date | 1984-06-22 |