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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
510(k) Number K022022
Device Name JOSTRA VENT CATHETERS, MODELS LV & HKV
Applicant
Jostra AG
478 Media Rd.
Oxford,  PA  19363
Applicant Contact KATHLEEN JOHNSON
Correspondent
Jostra AG
478 Media Rd.
Oxford,  PA  19363
Correspondent Contact KATHLEEN JOHNSON
Regulation Number870.4210
Classification Product Code
DWF  
Subsequent Product Code
DRA  
Date Received06/20/2002
Decision Date 09/11/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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