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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Continuous Flush
510(k) Number K921247
Device Name ZEPHYR INFUSION CATHETER
Applicant
Target Therapeutics
47201 Lakeview Blvd.
P.O. Box 5120
Freemont,  CA  94538
Applicant Contact CRAIG J COOMBS
Correspondent
Target Therapeutics
47201 Lakeview Blvd.
P.O. Box 5120
Freemont,  CA  94538
Correspondent Contact CRAIG J COOMBS
Regulation Number870.1210
Classification Product Code
KRA  
Date Received03/16/1992
Decision Date 06/29/1993
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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