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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K930194
Device Name HEMOSTASIS VALVE AND TUBING SET
Applicant
Opticon Medical, Inc.
806 Brian Ct.
Gurnee,  IL  60031
Applicant Contact JANE PATRICK
Correspondent
Opticon Medical, Inc.
806 Brian Ct.
Gurnee,  IL  60031
Correspondent Contact JANE PATRICK
Regulation Number870.1340
Classification Product Code
DYB  
Date Received01/14/1993
Decision Date 09/22/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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