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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, Orthopedic, Pneumatic Powered & Accessory/Attachment
510(k) Number K991588
Device Name EMS SWISS ORTHOCLAST
Applicant
(Ems Sa) Electro Medical Systems
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact SHEILA HAMEON-HEYER
Correspondent
(Ems Sa) Electro Medical Systems
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact SHEILA HAMEON-HEYER
Regulation Number878.4820
Classification Product Code
HSZ  
Subsequent Product Codes
GET   LZV  
Date Received05/07/1999
Decision Date 07/21/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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