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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rongeur, Manual
510(k) Number K023868
Device Name DAN KERRISON RONGEURS, MODELS K1 + BILLY 1
Applicant
Dannoritzer Medical Instruments
271 Waldroup Rd.
P.O. Box 457
Hot Springs,  NC  28783
Applicant Contact DAGMAR S MASER
Correspondent
Dannoritzer Medical Instruments
271 Waldroup Rd.
P.O. Box 457
Hot Springs,  NC  28783
Correspondent Contact DAGMAR S MASER
Regulation Number882.4840
Classification Product Code
HAE  
Date Received11/20/2002
Decision Date 02/07/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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