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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Cement Removal Extraction
510(k) Number K930629
Device Name ACRYL-X II SYSTEM
Applicant
Sonokinetics, Inc.
130 Washington St.
Suite 201
Hoboken,  NJ  07030
Applicant Contact DAVID WUCHINICH
Correspondent
Sonokinetics, Inc.
130 Washington St.
Suite 201
Hoboken,  NJ  07030
Correspondent Contact DAVID WUCHINICH
Regulation Number888.4580
Classification Product Code
LZV  
Subsequent Product Code
JDX  
Date Received02/08/1993
Decision Date 01/21/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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