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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 Factor Deficient
510(k) Number K981173
Device Name CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML)
Applicant
Precision Biologicals, Inc.
900 Windmill Rd.
Unit 100
Dartmouth, Nova Scotia,  CA B3B 1P7
Applicant Contact SANDY MORRISON
Correspondent
Precision Biologicals, Inc.
900 Windmill Rd.
Unit 100
Dartmouth, Nova Scotia,  CA B3B 1P7
Correspondent Contact SANDY MORRISON
Regulation Number864.7290
Classification Product Code
GJT  
Date Received04/01/1998
Decision Date 01/13/1999
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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