Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K830483 |
Device Name |
COONS SOFT STENT |
Applicant |
MEDI-TECH, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
MEDI-TECH, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 02/15/1983 |
Decision Date | 03/09/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|