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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 K833874
Device Name SHEA MIDDLE EAR MICRODRILL
Applicant
APPLIED RESEARCH CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
APPLIED RESEARCH CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number874.4250
Classification Product Code
ERL  
Date Received11/08/1983
Decision Date 06/22/1984
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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