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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 K792159
Device Name FISCH DRILL SYSTEM
Applicant
JEDMED INSTRUMENT CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
JEDMED INSTRUMENT CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number874.4250
Classification Product Code
ERL  
Date Received10/29/1979
Decision Date 11/27/1979
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
Recalls CDRH Recalls
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