The following data is part of a premarket notification filed by Kelleher Corp. with the FDA for Rosen's Stapes Needle Explorer.
| Device ID | K822277 |
| 510k Number | K822277 |
| Device Name: | ROSEN'S STAPES NEEDLE EXPLORER |
| Classification | Probe, Ent |
| Applicant | KELLEHER CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KAK |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-29 |
| Decision Date | 1982-08-25 |