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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K922254
Device Name LUKENS 2-0 BRAIDED SILK SUTURES
Applicant
Quinton, Inc.
2121 Terry Ave.
Seattle,  WA  98121
Applicant Contact GREG W SHIPP
Correspondent
Quinton, Inc.
2121 Terry Ave.
Seattle,  WA  98121
Correspondent Contact GREG W SHIPP
Regulation Number870.1200
Classification Product Code
DQO  
Date Received02/11/1992
Decision Date 09/01/1992
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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