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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 K070749
Device Name ESTECH PERCUTANEOUS INSERTION DILATOR KIT
Applicant
Coombs Medical Device Consulting
1193 Sherman St.
Alameda,  CA  94501
Applicant Contact CRAIG COOMBS
Correspondent
Coombs Medical Device Consulting
1193 Sherman St.
Alameda,  CA  94501
Correspondent Contact CRAIG COOMBS
Regulation Number870.1310
Classification Product Code
DRE  
Date Received03/19/2007
Decision Date 10/24/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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