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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile
510(k) Number K935774
Device Name CURITY FAST-CATH FEMALE CATHETER KIT
Applicant
Kendall Healthcare Products Co. Div.Of Tyco Health
15 Hampshire St.
Mansfield,  MA  02048
Applicant Contact DAVID A OLSON
Correspondent
Kendall Healthcare Products Co. Div.Of Tyco Health
15 Hampshire St.
Mansfield,  MA  02048
Correspondent Contact DAVID A OLSON
Regulation Number876.5250
Classification Product Code
EYT  
Date Received12/03/1993
Decision Date 04/11/1994
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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
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