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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 K813312
Device Name UNIVERSAL SUCTION PUMP TYPE EUS
Applicant
EGNELL, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
EGNELL, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4780
Classification Product Code
BTA  
Date Received11/24/1981
Decision Date 12/31/1981
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
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