Device Classification Name |
dilator, esophageal
|
510(k) Number |
K932015 |
Device Name |
TRI-MED INFLATABLE ESOPHAGEAL DILATOR |
Applicant |
TRI-MED SPECIALTIES, INC. |
P.O. BOX 23306 |
OVERLAND PARK,
KS
66223
|
|
Applicant Contact |
LARRY SCOTT |
Correspondent |
TRI-MED SPECIALTIES, INC. |
P.O. BOX 23306 |
OVERLAND PARK,
KS
66223
|
|
Correspondent Contact |
LARRY SCOTT |
Regulation Number | 876.5365
|
Classification Product Code |
|
Date Received | 04/23/1993 |
Decision Date | 02/03/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|