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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 W.
Valencia,  CA  91355
Applicant Contact MOE KHOSRAVI
Correspondent
Micro Surgical Instruments Corp.
C/O Zimmer,Inc.
24971 Ave.Stanford W.
Valencia,  CA  91355
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
Predetermined Change
Control Plan Authorized		 No
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