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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 K980592
Device Name NTECH CYSTOSCOPES
Applicant
N-TECH ENDOSCOPY, INC.
25775 A HILLVIEW CT.
MUNDELEIN,  IL  60060
Applicant Contact NICK SURO
Correspondent
N-TECH ENDOSCOPY, INC.
25775 A HILLVIEW CT.
MUNDELEIN,  IL  60060
Correspondent Contact NICK SURO
Regulation Number876.1500
Classification Product Code
FAJ  
Date Received02/17/1998
Decision Date 04/28/1998
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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