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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 K880231
Device Name MODIFIED PRUITT IRRIGATION & OCCLUSION CATHETER
Applicant
Ideas For Medicine, Inc.
12167 49th St. N.
P.O. Box 17327
Clearwater,  FL  34622
Applicant Contact LORNA K LINVILLE
Correspondent
Ideas For Medicine, Inc.
12167 49th St. N.
P.O. Box 17327
Clearwater,  FL  34622
Correspondent Contact LORNA K LINVILLE
Regulation Number870.1370
Classification Product Code
DQT  
Date Received01/13/1988
Decision Date 05/25/1988
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
Recalls CDRH Recalls
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