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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Portable, Aspiration (Manual Or Powered)
510(k) Number K850946
Device Name SURGICAL ASPIRATOR
Applicant
Medicalex
39 Rue Croulebarbe
Paris 75013,  FR
Applicant Contact ALDO LEVY
Correspondent
Medicalex
39 Rue Croulebarbe
Paris 75013,  FR
Correspondent Contact ALDO LEVY
Regulation Number878.4780
Classification Product Code
BTA  
Date Received03/07/1985
Decision Date 09/16/1985
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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