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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 K822008
Device Name TORX OR TYPE MICRO MOTOR HANDPIECE
Applicant
KELLEHER CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
KELLEHER CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number874.4250
Classification Product Code
ERL  
Date Received07/08/1982
Decision Date 08/12/1982
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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