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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K984142
Device Name SONICATOR PLUS 992, MODEL NUMBER ME 992 AND SONICATOR PLUS 994, MODEL NUMBER ME 994
Applicant
METTLER ELECTRONICS CORP.
1333 SOUTH CLAUDINA ST.
ANAHEIM,  CA  92805
Applicant Contact ROBERT E FLEMING
Correspondent
METTLER ELECTRONICS CORP.
1333 SOUTH CLAUDINA ST.
ANAHEIM,  CA  92805
Correspondent Contact ROBERT E FLEMING
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Codes
GZJ   LIH  
Date Received11/18/1998
Decision Date 02/09/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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