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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Surgical, General & Plastic Surgery
510(k) Number K904881
Device Name DISPOSABLE YANKAUER SUCTION TUBE
Applicant
Pilling Medical S.A.
Le Faget
Par Caraman, France 31460,  FR
Applicant Contact RIKA STEUPERAERT
Correspondent
Pilling Medical S.A.
Le Faget
Par Caraman, France 31460,  FR
Correspondent Contact RIKA STEUPERAERT
Regulation Number878.4800
Classification Product Code
GEA  
Date Received10/24/1990
Decision Date 03/06/1991
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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