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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name endoscopic injection needle, gastroenterology-urology
510(k) Number K001146
Device Name GENYX FLEXIBLE INJECTION NEEEDLE
Applicant
GENY MEDICAL, INC.
66 ARGONAUT # 170
ALISO VIEJO,  CA  92656
Applicant Contact JUDY F GORDON
Correspondent
GENY MEDICAL, INC.
66 ARGONAUT # 170
ALISO VIEJO,  CA  92656
Correspondent Contact JUDY F GORDON
Regulation Number876.1500
Classification Product Code
FBK  
Date Received04/10/2000
Decision Date 06/30/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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