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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K860429
Device Name MEADOX SURGIMED GUIDE CATHETER
Applicant
Meadox Surgimed, Inc.
112 Bauer Dr.
Oakland,  NJ  07436
Applicant Contact JAN AOYAGI
Correspondent
Meadox Surgimed, Inc.
112 Bauer Dr.
Oakland,  NJ  07436
Correspondent Contact JAN AOYAGI
Regulation Number870.1200
Classification Product Code
DQO  
Date Received02/04/1986
Decision Date 04/23/1986
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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