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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bur, Ear, Nose And Throat
510(k) Number K895738
Device Name MICROMEDICS EAR, NOSE AND THROAT BURS
Applicant
Micromedics, Inc.
268 E. Lafayette Frontage
Rd.
St. Paul,  MN  55107
Applicant Contact CURTIS H MILLER
Correspondent
Micromedics, Inc.
268 E. Lafayette Frontage
Rd.
St. Paul,  MN  55107
Correspondent Contact CURTIS H MILLER
Regulation Number874.4140
Classification Product Code
EQJ  
Date Received09/26/1989
Decision Date 12/19/1989
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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