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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgical Instruments, G-U, Manual (And Accessories)
510(k) Number K950267
Device Name URETHRAL SUTURE GUIDE
Applicant
APPLIED MEDICAL RESOURCES
26051 MERIT CIRCLE
BUILDING 104
LAGUNA HILLS,  CA  92653
Applicant Contact MARY JO S TEGWELL
Correspondent
APPLIED MEDICAL RESOURCES
26051 MERIT CIRCLE
BUILDING 104
LAGUNA HILLS,  CA  92653
Correspondent Contact MARY JO S TEGWELL
Regulation Number876.4730
Classification Product Code
KOA  
Date Received01/23/1995
Decision Date 01/31/1995
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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