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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 K925809
Device Name COMPRESSAR UNIVERSAL (TM) SYSTEM
Applicant
Instromedix, Inc.
One Technology Center
7431 NE Evergreen Pkwy.
Hillsboro,  OR  97124
Applicant Contact HERBERT J SEMLER
Correspondent
Instromedix, Inc.
One Technology Center
7431 NE Evergreen Pkwy.
Hillsboro,  OR  97124
Correspondent Contact HERBERT J SEMLER
Regulation Number870.4450
Classification Product Code
DXC  
Date Received11/17/1992
Decision Date 02/22/1993
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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