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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
510(k) Number K801764
Device Name IONESCU-SHILEY PERICARDIAL PATCH
Applicant
Shiley, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Shiley, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.3470
Classification Product Code
DXZ  
Date Received07/28/1980
Decision Date 08/13/1980
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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