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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Prebypass, Cardiopulmonary Bypass
510(k) Number K990276
FOIA Releasable 510(k) K990276
Device Name POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER
Applicant
Porous Media Corp.
1350 Hammond Rd.
St. Paul,  MN  55110
Applicant Contact ROCHELLE M MICKSCHL
Correspondent
Porous Media Corp.
1350 Hammond Rd.
St. Paul,  MN  55110
Correspondent Contact ROCHELLE M MICKSCHL
Regulation Number870.4280
Classification Product Code
KRJ  
Date Received01/28/1999
Decision Date 10/01/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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