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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 K971222
Device Name CRYO CHECK APC RESISTANT PLASMA
Applicant
Precision Biologicals, Inc.
900 Windmill Rd.
Unit 100
Dartmouth, Nova Scotia,  CA B3B 1P7
Applicant Contact STEPHEN L DUFF
Correspondent
Precision Biologicals, Inc.
900 Windmill Rd.
Unit 100
Dartmouth, Nova Scotia,  CA B3B 1P7
Correspondent Contact STEPHEN L DUFF
Regulation Number864.5425
Classification Product Code
GGN  
Date Received04/02/1997
Decision Date 08/19/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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