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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Vessel, Surgical
510(k) Number K130896
Device Name VASCULAR PROBE, VASCULAR PROBE ES
Applicant
Synovis Life Technologies, Inc.
2575 University Ave. W.
St. Paul,  MN  55114
Applicant Contact STEPHANI K AYALA
Correspondent
Synovis Life Technologies, Inc.
2575 University Ave. W.
St. Paul,  MN  55114
Correspondent Contact STEPHANI K AYALA
Regulation Number870.4475
Classification Product Code
DWP  
Date Received04/01/2013
Decision Date 04/24/2013
Decision Substantially Equivalent (SESE)
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
Recalls CDRH Recalls
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