Device Classification Name |
bougie, esophageal, and gastrointestinal, gastro-urology
|
510(k) Number |
K972119 |
Device Name |
MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX) |
Applicant |
MEDOVATIONS, INC. |
W194 N11340 MCCORMICK DR. |
GERMANTOWN,
WI
53022
|
|
Applicant Contact |
CHARLES G STANFORD |
Correspondent |
MEDOVATIONS, INC. |
W194 N11340 MCCORMICK DR. |
GERMANTOWN,
WI
53022
|
|
Correspondent Contact |
CHARLES G STANFORD |
Regulation Number | 876.5365
|
Classification Product Code |
|
Date Received | 06/05/1997 |
Decision Date | 02/02/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|