The following data is part of a premarket notification filed by Kelleher Corp. with the FDA for Ent Retractors.
| Device ID | K822163 |
| 510k Number | K822163 |
| Device Name: | ENT RETRACTORS |
| Classification | Hearing Aid, Air Conduction |
| Applicant | KELLEHER CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-23 |
| Decision Date | 1982-08-11 |