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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 K843719
Device Name SINGLE WALL INTRODUCER NEEDLE
Applicant
Ocean Medical Products, Ltd.
2131 Martindale
Wyoming,  MI  49509
Applicant Contact ALAN TAYLOR
Correspondent
Ocean Medical Products, Ltd.
2131 Martindale
Wyoming,  MI  49509
Correspondent Contact ALAN TAYLOR
Regulation Number870.1340
Classification Product Code
DYB  
Date Received09/24/1984
Decision Date 10/18/1984
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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