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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 K963716
Device Name MICS DEVICE SYSTEM
Applicant
Percutaneous Technologies, Inc.
773 Trotter Court
Walnut,  CA  91789
Applicant Contact WILLIAM MEYER
Correspondent
Percutaneous Technologies, Inc.
773 Trotter Court
Walnut,  CA  91789
Correspondent Contact WILLIAM MEYER
Regulation Number870.4450
Classification Product Code
DXC  
Date Received09/16/1996
Decision Date 04/02/1997
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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