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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 K914008
Device Name PENTAX CYSTOFIBERSCOPE, MODEL FCY-15P
Applicant
PENTAX PRECISION INSTRUMENT CORP.
30 RAMLAND RD.
ORANGEBURG,  NY  10962
Applicant Contact LORRAINE SCHWARTZ
Correspondent
PENTAX PRECISION INSTRUMENT CORP.
30 RAMLAND RD.
ORANGEBURG,  NY  10962
Correspondent Contact LORRAINE SCHWARTZ
Regulation Number876.1500
Classification Product Code
FAJ  
Date Received09/09/1991
Decision Date 01/10/1992
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
Recalls CDRH Recalls
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