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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 K915139
Device Name MODEL 2250-000 ZIMMER STYLE SAGITTAL SAW MODULE
Applicant
Micro Surgical Instruments Corp.
24971 Ave. Stanford W.
Valencia,  CA  91355
Applicant Contact MOE KHOSRAVI
Correspondent
Micro Surgical Instruments Corp.
24971 Ave. Stanford W.
Valencia,  CA  91355
Correspondent Contact MOE KHOSRAVI
Regulation Number878.4820
Classification Product Code
HSZ  
Date Received11/13/1991
Decision Date 02/05/1992
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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