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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name test, time, prothrombin
510(k) Number K791023
Device Name PROTHROMBIN FREE BEEF PLASMA (PFB)
Applicant
PACIFIC HEMOSTASIS
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
PACIFIC HEMOSTASIS
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number864.7750
Classification Product Code
GJS  
Date Received05/30/1979
Decision Date 06/28/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
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