Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K974815 |
Device Name |
MANAN(TM) INTRODUCER SHEATH/NEEDLE |
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 Number | 876.5010
|
Classification Product Code |
|
Date Received | 12/23/1997 |
Decision Date | 01/09/1998 |
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
|
|
|