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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stylet for catheter, gastro-urology
510(k) Number K971498
Device Name APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE
Applicant
APPLIED MEDICAL RESOURCES
26051 MERIT CIRCLE
BUILDING 104
LAGUNA HILLS,  CA  92653
Applicant Contact HOWARD V ROWE
Correspondent
APPLIED MEDICAL RESOURCES
26051 MERIT CIRCLE
BUILDING 104
LAGUNA HILLS,  CA  92653
Correspondent Contact HOWARD V ROWE
Regulation Number876.5130
Classification Product Code
EZB  
Subsequent Product Code
FZX  
Date Received04/25/1997
Decision Date 05/05/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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