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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, retention type, balloon
510(k) Number K941488
Device Name DEVMED DOUBLE-BALLOON UROLOGICAL CATHETER
Applicant
MEDICAL TECHNOLOGY DEVELOPMENT CORP.
P.O. BOX 1029
SANTA YNEZ,  CA  93460
Applicant Contact PAMELA G GOFORTH
Correspondent
MEDICAL TECHNOLOGY DEVELOPMENT CORP.
P.O. BOX 1029
SANTA YNEZ,  CA  93460
Correspondent Contact PAMELA G GOFORTH
Regulation Number876.5130
Classification Product Code
EZL  
Date Received03/28/1994
Decision Date 11/30/1994
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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