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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Beads, Hydrophilic, For Wound Exudate Absorption
510(k) Number K844625
Device Name BIPORE O.2 MICRON HYDROPHOBIC FILTER ASSEMBLY
Applicant
Bipore, Inc.
16 Edward St.
Demarest,  NJ  07627
Applicant Contact ELIZABETH KOCH
Correspondent
Bipore, Inc.
16 Edward St.
Demarest,  NJ  07627
Correspondent Contact ELIZABETH KOCH
Regulation Number878.4018
Classification Product Code
KOZ  
Date Received11/27/1984
Decision Date 01/16/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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