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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Vascular
510(k) Number K982278
Device Name MICRINS MICRO ANASTOMOSIS CLAMP
Applicant
MICRINS SURGICAL, INC.
28438 BALLARD DR.
LAKE FOREST,  IL  60045
Applicant Contact BERNHARD TEITZ
Correspondent
MICRINS SURGICAL, INC.
28438 BALLARD DR.
LAKE FOREST,  IL  60045
Correspondent Contact BERNHARD TEITZ
Regulation Number870.4450
Classification Product Code
DXC  
Date Received06/29/1998
Decision Date 03/26/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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