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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, multiple lumen
510(k) Number K844889
Device Name MENSINK-GOOSEN CATHETER
Applicant
GOOSEN ENTERPRISES, INC.
P.O. BOX 10
GOLDENROD,  FL  32733
Correspondent
GOOSEN ENTERPRISES, INC.
P.O. BOX 10
GOLDENROD,  FL  32733
Regulation Number878.4200
Classification Product Code
GBP  
Date Received12/17/1984
Decision Date 03/18/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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