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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 K011601
Device Name ARDO SUCTION PUMP MASTER, MODEL 30.00.XX; ARDO SUCTION PUMP SENATOR, MODEL 31.00.XX
Applicant
ARDO MEDICAL AG
GEWERBESTRASSE 19
UNTERAGERI,  CH CH-6314
Applicant Contact EVA KRAHENBUHL
Correspondent
TUV PRODUCT SERVICE, INC.
1775 OLD HIGHWAY 8
NEW BRIGHTON,  MN  55112 -1891
Correspondent Contact MARK JOB
Regulation Number878.4780
Classification Product Code
BTA  
Date Received05/24/2001
Decision Date 06/08/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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