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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Vessel, For Percutaneous Catheterization
510(k) Number K023507
Device Name MODIFICATION TO GELBFISH VASCULAR DILATORS
Applicant
Vascumetrix, LLC
2824 N. Power Rd., #113-278
Mesa,  AZ  85215 -1674
Applicant Contact NICK RAIBLE
Correspondent
Vascumetrix, LLC
2824 N. Power Rd., #113-278
Mesa,  AZ  85215 -1674
Correspondent Contact NICK RAIBLE
Regulation Number870.1310
Classification Product Code
DRE  
Date Received10/18/2002
Decision Date 11/08/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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