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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K842501
Device Name TSS/FIK
Applicant
Zarcon Corp.
P.O. Box 428
2000 Allston Way
Berkeley,  CA  94701
Applicant Contact CHARLES E KIMBLE
Correspondent
Zarcon Corp.
P.O. Box 428
2000 Allston Way
Berkeley,  CA  94701
Correspondent Contact CHARLES E KIMBLE
Date Received06/26/1984
Decision Date 03/12/1985
Decision Substantially Equivalent (SESE)
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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