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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 K962163
Device Name MISTEN MEDICAL MISTEN MEDICAL SURGICAL DRILL
Applicant
MISTEN MEDICAL CORP.
7220 STOUT RD.
GERMANTOWN,  TN  38138
Applicant Contact GEORGE W MURRAY
Correspondent
MISTEN MEDICAL CORP.
7220 STOUT RD.
GERMANTOWN,  TN  38138
Correspondent Contact GEORGE W MURRAY
Regulation Number874.4250
Classification Product Code
ERL  
Date Received06/04/1996
Decision Date 07/25/1996
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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