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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K873972
Device Name GUIDE WIRE INTRODUCER
Applicant
Target Therapeutics
2100 S. Sepulveda Blvd.
Los Angeles,  CA  90025
Applicant Contact JONI M SNYDER
Correspondent
Target Therapeutics
2100 S. Sepulveda Blvd.
Los Angeles,  CA  90025
Correspondent Contact JONI M SNYDER
Regulation Number870.1330
Classification Product Code
DQX  
Date Received09/29/1987
Decision Date 04/01/1988
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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