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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 K980982
Device Name AVOCET SYSTEM LIQUID CONTROL LEVEL 1 AND LEVEL 2
Applicant
Avocet Medical, Inc.
1696 Dell Ave.
Campbell,  CA  95008
Applicant Contact Judith Blunt
Correspondent
Avocet Medical, Inc.
1696 Dell Ave.
Campbell,  CA  95008
Correspondent Contact Judith Blunt
Regulation Number864.5425
Classification Product Code
GGN  
Subsequent Product Code
JPA  
Date Received03/17/1998
Decision Date 04/16/1998
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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