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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cystoscope and accessories, flexible/rigid
510(k) Number K970892
Device Name FIEGERT ENDOTECH CYSTOSCOPE
Applicant
FIEGERT, INC.
TWO OAKWOOD BLVD. SUITE 160
HOLLYWOOD,  FL  33020
Applicant Contact ERNESTO HERNANDEZ
Correspondent
FIEGERT, INC.
TWO OAKWOOD BLVD. SUITE 160
HOLLYWOOD,  FL  33020
Correspondent Contact ERNESTO HERNANDEZ
Regulation Number876.1500
Classification Product Code
FAJ  
Date Received03/11/1997
Decision Date 05/05/1997
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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