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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, Electric
510(k) Number K022986
Device Name THE BIOPLATE BATTERY POWERED DRILL
Applicant
Bioplate, Inc.
815 Connecticut Ave. NW
Washington,  DC  20006
Applicant Contact BRUCE F MACKLER
Correspondent
Bioplate, Inc.
815 Connecticut Ave. NW
Washington,  DC  20006
Correspondent Contact BRUCE F MACKLER
Regulation Number882.4360
Classification Product Code
HBC  
Date Received09/09/2002
Decision Date 11/19/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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