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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Multipurpose For In Vitro Coagulation Studies
510(k) Number K884534
Device Name PALL HEPCHEK (TM) HEPARIN ABSORPTION FILTER
Applicant
Pall Biomedical Products Co.
77 Crescent Beach Rd.
Glen Cove,  NY  11542
Applicant Contact SAMUEL T WORTHAM
Correspondent
Pall Biomedical Products Co.
77 Crescent Beach Rd.
Glen Cove,  NY  11542
Correspondent Contact SAMUEL T WORTHAM
Regulation Number864.5425
Classification Product Code
JPA  
Date Received10/28/1988
Decision Date 01/24/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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