Device Classification Name |
Monitor, Esophageal Motility, Anorectal Motility, And Tube
|
510(k) Number |
K914793 |
Device Name |
MONOCRYSTANT PH/LES CATHETER, MODIFICATION |
Applicant |
SYNECTICS-DANTEC |
RENSTIENAS GATA 12, 5TR. |
S-116 28 STOCKHOLM |
SWEDEN,
SE
S-116 28
|
|
Applicant Contact |
ANNA PETTERSSON |
Correspondent |
SYNECTICS-DANTEC |
RENSTIENAS GATA 12, 5TR. |
S-116 28 STOCKHOLM |
SWEDEN,
SE
S-116 28
|
|
Correspondent Contact |
ANNA PETTERSSON |
Regulation Number | 876.1725
|
Classification Product Code |
|
Date Received | 08/26/1991 |
Decision Date | 12/13/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|