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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, straight
510(k) Number K923848
Device Name GOOSEN SELF-LUBRICATING CATHETER
Applicant
GOOSEN ENTERPRISES, INC.
P.O. BOX 10
GOLDENROD,  FL  32733
Applicant Contact CARL C GOOSEN
Correspondent
GOOSEN ENTERPRISES, INC.
P.O. BOX 10
GOLDENROD,  FL  32733
Correspondent Contact CARL C GOOSEN
Regulation Number876.5130
Classification Product Code
EZD  
Date Received07/31/1992
Decision Date 02/18/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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