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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 K872154
Device Name MODIFIED INFO INSERTS FOR PRUITT IRRI.-OCCLU. CATH
Applicant
Ideas For Medicine, Inc.
12167 49th St. N.
P.O. Box 17327
Clearwater,  FL  34622
Applicant Contact MARK R WADDELL
Correspondent
Ideas For Medicine, Inc.
12167 49th St. N.
P.O. Box 17327
Clearwater,  FL  34622
Correspondent Contact MARK R WADDELL
Regulation Number870.1370
Classification Product Code
DQT  
Date Received06/01/1987
Decision Date 08/03/1987
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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