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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ureteroscope And Accessories, Flexible/Rigid
510(k) Number K926004
Device Name ENDOSCOPE AND ACCOSSORIES
Applicant
Endomedix
2162 Michelson Dr.
Irvine,  CA  92715
Applicant Contact LEIGH WEINTRAUB
Correspondent
Endomedix
2162 Michelson Dr.
Irvine,  CA  92715
Correspondent Contact LEIGH WEINTRAUB
Regulation Number876.1500
Classification Product Code
FGB  
Date Received11/27/1992
Decision Date 02/10/1993
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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