The following data is part of a premarket notification filed by Applied Research Corp. with the FDA for Shea Middle Ear Microdrill.
| Device ID | K833874 |
| 510k Number | K833874 |
| Device Name: | SHEA MIDDLE EAR 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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169882676 | K833874 | 000 |
| 00643169350670 | K833874 | 000 |
| 00681490070348 | K833874 | 000 |
| 00681490066907 | K833874 | 000 |
| 00681490066846 | K833874 | 000 |
| 00763000378004 | K833874 | 000 |