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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prothrombin Fragment 1.2
510(k) Number K962176
Device Name TPP
Applicant
Panbio, Inc.
1539 N. Ironwood Dr.
South Bend,  IN  46635
Applicant Contact CHRISTOPHER NOTESTINE
Correspondent
Panbio, Inc.
1539 N. Ironwood Dr.
South Bend,  IN  46635
Correspondent Contact CHRISTOPHER NOTESTINE
Regulation Number864.7320
Classification Product Code
MIF  
Date Received06/05/1996
Decision Date 10/18/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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