Device Classification Name |
system, gastrointestinal motility (electrical)
|
510(k) Number |
K963064 |
Device Name |
ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM |
Applicant |
LABORIE MEDICAL TECH CORP. |
6 HURRICANE LANE, #2 |
WILLISTON,
VT
05495
|
|
Applicant Contact |
THOMAS HIRTE |
Correspondent |
LABORIE MEDICAL TECH CORP. |
6 HURRICANE LANE, #2 |
WILLISTON,
VT
05495
|
|
Correspondent Contact |
THOMAS HIRTE |
Regulation Number | 876.1725
|
Classification Product Code |
|
Date Received | 08/07/1996 |
Decision Date | 06/05/1997 |
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
|
|
|