The following data is part of a premarket notification filed by Dannoritzer Medical Instruments with the FDA for Dan Kerrison Rongeurs, Models K1 + Billy 1.
| Device ID | K023868 |
| 510k Number | K023868 |
| Device Name: | DAN KERRISON RONGEURS, MODELS K1 + BILLY 1 |
| Classification | Rongeur, Manual |
| Applicant | DANNORITZER MEDICAL INSTRUMENTS 271 WALDROUP RD. P.O. BOX 457 Hot Springs, NC 28783 |
| Contact | Dagmar S Maser |
| Correspondent | Dagmar S Maser DANNORITZER MEDICAL INSTRUMENTS 271 WALDROUP RD. P.O. BOX 457 Hot Springs, NC 28783 |
| Product Code | HAE |
| CFR Regulation Number | 882.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-20 |
| Decision Date | 2003-02-07 |