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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 K935232
Device Name HYDROTORQUE GUIDE WIRE
Applicant
Kingston Technologies, Inc.
2235 Rte. 130
Dayton,  NJ  08810
Applicant Contact KEN BLASHKA
Correspondent
Kingston Technologies, Inc.
2235 Rte. 130
Dayton,  NJ  08810
Correspondent Contact KEN BLASHKA
Regulation Number870.1330
Classification Product Code
DQX  
Date Received11/01/1993
Decision Date 07/20/1994
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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