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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Occluder, Catheter Tip
510(k) Number K880860
Device Name CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015
Applicant
Dlp, Inc.
P.O.Box 409
620 Watsons SW
Grand Rapids,  MI  49501
Applicant Contact VAN HOF
Correspondent
Dlp, Inc.
P.O.Box 409
620 Watsons SW
Grand Rapids,  MI  49501
Correspondent Contact VAN HOF
Regulation Number870.1370
Classification Product Code
DQT  
Date Received03/01/1988
Decision Date 05/26/1988
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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