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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps, General & Plastic Surgery
510(k) Number K851673
Device Name RAKA OCH BOSDA PEANGER
Applicant
General Electric Trading Co.
570 Lexington Ave.
New York,  NY  10022
Applicant Contact HIDEO MARUKI
Correspondent
General Electric Trading Co.
570 Lexington Ave.
New York,  NY  10022
Correspondent Contact HIDEO MARUKI
Regulation Number878.4800
Classification Product Code
GEN  
Date Received04/23/1985
Decision Date 05/29/1985
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
Predetermined Change
Control Plan Authorized		 No
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