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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name rasp, surgical, general & plastic surgery
510(k) Number K853601
Device Name MORGAN ARTHROSCOPIC MENESUS & SYNOVIAL RASP
Applicant
BOWEN & COMPANY, INC.
1800 CHAPMAN AVE.
ROCKVILLE,  MD  20852
Applicant Contact CAROL APPLE
Correspondent
BOWEN & COMPANY, INC.
1800 CHAPMAN AVE.
ROCKVILLE,  MD  20852
Correspondent Contact CAROL APPLE
Regulation Number878.4800
Classification Product Code
GAC  
Date Received08/27/1985
Decision Date 09/16/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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