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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 K873766
Device Name STERNAL POWER AWL
Applicant
Bowen & Company, Inc.
1800 Chapman Ave.
Rockville,  MD  20852
Applicant Contact SUSAN BRANDT
Correspondent
Bowen & Company, Inc.
1800 Chapman Ave.
Rockville,  MD  20852
Correspondent Contact SUSAN BRANDT
Regulation Number878.4820
Classification Product Code
KIJ  
Date Received09/16/1987
Decision Date 11/14/1988
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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