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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple Driver
510(k) Number K930205
Device Name ELECTRIC WIRE DRIVER, MODEL 2640E
Applicant
Micro Surgical Instruments Corp.
24971 Ave. Stanford W.
Valencia,  CA  91355
Applicant Contact SHIRAJUL KARIM
Correspondent
Micro Surgical Instruments Corp.
24971 Ave. Stanford W.
Valencia,  CA  91355
Correspondent Contact SHIRAJUL KARIM
Regulation Number888.4540
Classification Product Code
HXJ  
Date Received01/15/1993
Decision Date 08/02/1993
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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