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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Motor, Drill, Pneumatic
510(k) Number K895739
Device Name MICROMEDICS SURGICAL DRILL SYSTEM
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 Number882.4370
Classification Product Code
HBB  
Date Received09/26/1989
Decision Date 10/13/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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