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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Intravascular Catheter Securement
510(k) Number K924567
Device Name FOLEY CATHETER TUBE HOLDER NO. 101
Applicant
Ansley Medical Products, Inc.
4201 Kellway Cir.
Dallas,  TX  75244
Applicant Contact SHARON D CHEATWOOD
Correspondent
Ansley Medical Products, Inc.
4201 Kellway Cir.
Dallas,  TX  75244
Correspondent Contact SHARON D CHEATWOOD
Regulation Number880.5210
Classification Product Code
KMK  
Date Received09/09/1992
Decision Date 11/23/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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