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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 K923681
Device Name EXONOX PERCUTANEOUS INTRODUCER SYSTEM W/ HEMOSTASI
Applicant
Exonix Research Corp.
9344 NW 13 St.
Miami,  FL  33172
Applicant Contact OSCAR JIMENEZ
Correspondent
Exonix Research Corp.
9344 NW 13 St.
Miami,  FL  33172
Correspondent Contact OSCAR JIMENEZ
Regulation Number870.1340
Classification Product Code
DYB  
Date Received07/22/1992
Decision Date 01/21/1993
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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