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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 K971225
Device Name CRYO CHECK FACTOR VIII DEFICIENT 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 Number864.7290
Classification Product Code
GJT  
Date Received04/02/1997
Decision Date 07/17/1997
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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