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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name tray, catheterization, sterile urethral, with or without catheter (kit)
510(k) Number K950109
Device Name CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY/WITH OUT CATHETER
Applicant
CYPRESS MEDICAL PRODUCTS, LTD.
1202 SOUTH ROUTE 31
MCHENRY,  IL  60050
Applicant Contact KEN RYSSO
Correspondent
CYPRESS MEDICAL PRODUCTS, LTD.
1202 SOUTH ROUTE 31
MCHENRY,  IL  60050
Correspondent Contact KEN RYSSO
Regulation Number876.5130
Classification Product Code
FCM  
Date Received01/11/1995
Decision Date 02/27/1995
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
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