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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vessel Guard Or Cover
510(k) Number K082782
Device Name REPLICATION MEDICAL VESSEL GUARD
Applicant
Replication Medical, Inc.
901 King St., Suite 200
Alexandria,  VA  22314
Applicant Contact MARCOS VELEZ-DURAN
Correspondent
Replication Medical, Inc.
901 King St., Suite 200
Alexandria,  VA  22314
Correspondent Contact MARCOS VELEZ-DURAN
Regulation Number870.3470
Classification Product Code
OMR  
Date Received09/22/2008
Decision Date 04/02/2009
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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