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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Microsurgical
510(k) Number K831071
Device Name UNIVERSAL INSTRU. SET FOR NEUROVASCULAR
Applicant
Prothia USA, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Prothia USA, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number882.4525
Classification Product Code
GZX  
Date Received04/04/1983
Decision Date 06/08/1983
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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