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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Ultrasound, Intravascular
510(k) Number K041134
Device Name COMBOMAP PRESSURE AND FLOW SYSTEM
Applicant
Volcano Therapeutics, Inc.
2870 Kilgore Rd..
Rancho Cordova,,  CA  95670
Applicant Contact LORRY W HUFFMAN
Correspondent
Volcano Therapeutics, Inc.
2870 Kilgore Rd..
Rancho Cordova,,  CA  95670
Correspondent Contact LORRY W HUFFMAN
Regulation Number870.1200
Classification Product Code
OBJ  
Date Received04/30/2004
Decision Date 06/02/2004
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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