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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 K923085
Device Name QUICKLAMP SYSTEM
Applicant
Disco, Inc.
1860 Willamette Dr.
West Linn,  OR  97068
Applicant Contact BRYON G ZAHLER
Correspondent
Disco, Inc.
1860 Willamette Dr.
West Linn,  OR  97068
Correspondent Contact BRYON G ZAHLER
Regulation Number870.4450
Classification Product Code
DXC  
Date Received06/25/1992
Decision Date 02/12/1993
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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