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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
510(k) Number K800311
Device Name 450 DRILL/800 DRILL
Applicant
Black & Decker(Tm)
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Black & Decker(Tm)
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number878.4820
Classification Product Code
KIJ  
Date Received02/12/1980
Decision Date 02/22/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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