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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Flow Directed
510(k) Number K811276
Device Name OCCLUSION CATHETER
Applicant
Bionomy, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Bionomy, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number870.1240
Classification Product Code
DYG  
Date Received05/08/1981
Decision Date 06/30/1981
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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