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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, malecot
510(k) Number K981258
Device Name MANAN MALECOT BASKET DRAINAGE CATHETER
Applicant
MEDICAL DEVICE TECHNOLOGIES, INC.
4445 SW 35TH TERRACE
SUITE 310
GAINESVILLE,  FL  32608
Applicant Contact KARL SWARTZ
Correspondent
MEDICAL DEVICE TECHNOLOGIES, INC.
4445 SW 35TH TERRACE
SUITE 310
GAINESVILLE,  FL  32608
Correspondent Contact KARL SWARTZ
Regulation Number876.5090
Classification Product Code
FEW  
Date Received04/06/1998
Decision Date 04/22/1998
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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