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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stents, drains and dilators for the biliary ducts
510(k) Number K990808
Device Name PBN DILATORS
Applicant
MEDICAL DEVICE TECHNOLOGIES, INC.
3600 SW 47TH AVENUE
GAINESVILLE,  FL  32608
Applicant Contact KARL SWARTZ
Correspondent
MEDICAL DEVICE TECHNOLOGIES, INC.
3600 SW 47TH AVENUE
GAINESVILLE,  FL  32608
Correspondent Contact KARL SWARTZ
Regulation Number876.5010
Classification Product Code
FGE  
Subsequent Product Codes
GCC   LJE  
Date Received03/11/1999
Decision Date 11/26/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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