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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 K013585
Device Name MEDIPORT 2000 MOBILE
Applicant
SERVOX MEDIZINTECHNIK GMBH
69 SERVATIUSSTRASSE
POSTAL CODE 51109
KOLN,  DE 51109
Applicant Contact MARTIN HERBERG
Correspondent
SERVOX MEDIZINTECHNIK GMBH
69 SERVATIUSSTRASSE
POSTAL CODE 51109
KOLN,  DE 51109
Correspondent Contact MARTIN HERBERG
Regulation Number878.4780
Classification Product Code
BTA  
Date Received10/30/2001
Decision Date 01/28/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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