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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 K853909
Device Name EGNELL UNIVERSAL SUCTION PUMP
Applicant
EGNELL, INC.
333 W. WACKER DR.
SUITE 1900
CHICAGO,  IL  60606
Applicant Contact JOHN F LEMKER
Correspondent
EGNELL, INC.
333 W. WACKER DR.
SUITE 1900
CHICAGO,  IL  60606
Correspondent Contact JOHN F LEMKER
Regulation Number878.4780
Classification Product Code
BTA  
Date Received09/20/1985
Decision Date 11/25/1985
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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