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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name plasma, coagulation control
510(k) Number K051472
Device Name BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR
Applicant
HYPHEN BIOMED
6560 GOVE CT.
MASON,  OH  45040
Applicant Contact OLA ANDERSON
Correspondent
HYPHEN BIOMED
6560 GOVE CT.
MASON,  OH  45040
Correspondent Contact OLA ANDERSON
Regulation Number864.5425
Classification Product Code
GGN  
Subsequent Product Codes
GGC   KFF  
Date Received06/03/2005
Decision Date 12/23/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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