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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 K943635
Device Name ULTRA-LINE RONGEUR
Applicant
V. Mueller Neuro/Spine
871 Industrial Rd.
San Carlos,  CA  94070
Applicant Contact TERRY JOHNSTON
Correspondent
V. Mueller Neuro/Spine
871 Industrial Rd.
San Carlos,  CA  94070
Correspondent Contact TERRY JOHNSTON
Regulation Number882.4840
Classification Product Code
HAE  
Date Received07/27/1994
Decision Date 12/07/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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