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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauze/Sponge, Internal
510(k) Number K850093
Device Name PANAMEDIC GAUZE SPONGES
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
Classification Product Code
EFQ  
Date Received01/11/1985
Decision Date 02/21/1985
Decision Substantially Equivalent (SESE)
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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