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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 K831946
Device Name SURGICAL DRILL-ELECTRIC-HANDPIECE
Applicant
Entronics
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Entronics
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number874.4250
Classification Product Code
ERL  
Date Received06/16/1983
Decision Date 11/03/1983
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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