Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K930456 |
Device Name |
INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR |
Applicant |
INTERVENTIONAL THERAPEUTICS CORP. |
2665 MARINE WAY |
MOUNTAIN VIEW,
CA
94043
|
|
Applicant Contact |
COLIN J NICHOLS |
Correspondent |
INTERVENTIONAL THERAPEUTICS CORP. |
2665 MARINE WAY |
MOUNTAIN VIEW,
CA
94043
|
|
Correspondent Contact |
COLIN J NICHOLS |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 01/27/1993 |
Decision Date | 11/17/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|