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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name drill, surgical, ent (electric or pneumatic) including handpiece
510(k) Number K914346
Device Name DRILL MODULES MODELS 2116/2117
Applicant
MICRO SURGICAL INSTRUMENTS CORP.
C/O ZIMMER,INC.
24971 AVE.STANFORD WEST
valencia,  CA  91355 -1278
Applicant Contact moe khosravi
Correspondent
MICRO SURGICAL INSTRUMENTS CORP.
C/O ZIMMER,INC.
24971 AVE.STANFORD WEST
valencia,  CA  91355 -1278
Correspondent Contact moe khosravi
Regulation Number874.4250
Classification Product Code
ERL  
Date Received09/27/1991
Decision Date 11/27/1991
Decision substantially equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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