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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Catheter, G-U
510(k) Number K944135
Device Name UROLOGICAL GUIDWIRE
Applicant
Applied Medical Resources
26051 Merit Cir.
Bldg. 104
Launa Hills,  CA  92653
Applicant Contact MARY JO STEGWELL
Correspondent
Applied Medical Resources
26051 Merit Cir.
Bldg. 104
Launa Hills,  CA  92653
Correspondent Contact MARY JO STEGWELL
Regulation Number876.5130
Classification Product Code
KNY  
Subsequent Product Code
EZB  
Date Received08/24/1994
Decision Date 09/21/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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