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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 K902274
Device Name CUSTOMED CYSTO PACK I
Applicant
CUSTOMED, INC.
BOX 7699
CAROLINA
PUERTO RICO, 
Applicant Contact FELIX B SANTOS
Correspondent
CUSTOMED, INC.
BOX 7699
CAROLINA
PUERTO RICO, 
Correspondent Contact FELIX B SANTOS
Regulation Number876.1500
Classification Product Code
FAJ  
Date Received05/21/1990
Decision Date 09/20/1990
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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