The following data is part of a premarket notification filed by Kelleher Corp. with the FDA for Ent Mallets.
| Device ID | K822204 |
| 510k Number | K822204 |
| Device Name: | ENT MALLETS |
| Classification | Mallet, Surgical, General & Plastic Surgery |
| Applicant | KELLEHER CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GFJ |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-23 |
| Decision Date | 1982-09-17 |