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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, Ac-Powered Motor And Accessory/Attachment
510(k) Number K961759
Device Name CEMENT AND BONE REMOVAL KIT
Applicant
Maillefer Instruments S.A.
4084 Cliffrose Ave.
Moorpark,  CA  93021
Applicant Contact LEONARD A LERITZ
Correspondent
Maillefer Instruments S.A.
4084 Cliffrose Ave.
Moorpark,  CA  93021
Correspondent Contact LEONARD A LERITZ
Regulation Number878.4820
Classification Product Code
HWE  
Date Received05/07/1996
Decision Date 06/13/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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