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 |