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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 K931386
Device Name HEMASHIELD MICROVEL/WOVEN DOUBLE VELOUR FABRIC
Applicant
Meadox Medicals, Div. Boston Scientific Corp.
112 Bauer Dr.
Oakland,  NJ  07436
Applicant Contact PATRICIA CHRISTIAN
Correspondent
Meadox Medicals, Div. Boston Scientific Corp.
112 Bauer Dr.
Oakland,  NJ  07436
Correspondent Contact PATRICIA CHRISTIAN
Regulation Number870.3470
Classification Product Code
DXZ  
Date Received03/18/1993
Decision Date 05/27/1993
Decision SE - Postmarket Surveillance Required (SESP)
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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