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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Surgical, Sonic And Accessory/Attachment
510(k) Number K002484
Device Name EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL
Applicant
Electro Medical Systems SA
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact SHEILA HEMEON-HEYER
Correspondent
Electro Medical Systems SA
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact SHEILA HEMEON-HEYER
Regulation Number888.4580
Classification Product Code
JDX  
Subsequent Product Codes
GET   HSX   LZV  
Date Received08/14/2000
Decision Date 10/04/2000
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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