Device Classification Name |
Dilator, Esophageal
|
510(k) Number |
K971615 |
Device Name |
PATTISON ESOPHAGEAL DILATOR |
Applicant |
TRI-MED SPECIALTIES, INC. |
16309 WEST 108TH CIRCLE |
LENEXA,
KS
66219
|
|
Applicant Contact |
MIKE KNOTH |
Correspondent |
TRI-MED SPECIALTIES, INC. |
16309 WEST 108TH CIRCLE |
LENEXA,
KS
66219
|
|
Correspondent Contact |
MIKE KNOTH |
Regulation Number | 876.5365
|
Classification Product Code |
|
Date Received | 05/02/1997 |
Decision Date | 07/24/1997 |
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
|
|
|