Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K010798 |
Device Name |
RUSCH CANTOR TUBE |
Applicant |
RUSCH INTL. |
50 PLANTATION DR. |
JAFFERY,
NH
03452
|
|
Applicant Contact |
JULIE A BEAUMONT |
Correspondent |
RUSCH INTL. |
50 PLANTATION DR. |
JAFFERY,
NH
03452
|
|
Correspondent Contact |
JULIE A BEAUMONT |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 03/16/2001 |
Decision Date | 02/26/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|