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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 K960872
Device Name CYSTOSCOPE 0/15/30/70 DEGREES
Applicant
Pollux Endoscopy, Inc.
4696 NW 103rd Ave.
Sunrise,  FL  33351
Applicant Contact PRECIOUS J RESCH
Correspondent
Pollux Endoscopy, Inc.
4696 NW 103rd Ave.
Sunrise,  FL  33351
Correspondent Contact PRECIOUS J RESCH
Regulation Number876.1500
Classification Product Code
FAJ  
Date Received03/04/1996
Decision Date 05/07/1996
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
Predetermined Change
Control Plan Authorized		 No
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