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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Bacterial, Breathing-Circuit
510(k) Number K952428
Device Name POROUS MEDIA DBF23-R REUSABLE RESPIRATORY FILTER
Applicant
Porous Media Corp.
1350 Hammond Rd.
St. Paul,  MN  55110
Applicant Contact KEITH A ROBERTS
Correspondent
Porous Media Corp.
1350 Hammond Rd.
St. Paul,  MN  55110
Correspondent Contact KEITH A ROBERTS
Regulation Number868.5260
Classification Product Code
CAH  
Date Received05/24/1995
Decision Date 07/07/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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