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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plasma, Coagulase, Human, Horse And Rabbit
510(k) Number K883333
Device Name RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENT
Applicant
Immuno-Mycologics, Inc.
P.O. Box 1151
Norman,  OK  73070
Applicant Contact BAUMAN, PHD
Correspondent
Immuno-Mycologics, Inc.
P.O. Box 1151
Norman,  OK  73070
Correspondent Contact BAUMAN, PHD
Regulation Number866.2160
Classification Product Code
JTL  
Date Received08/09/1988
Decision Date 08/25/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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