Device Classification Name |
gastroscope and accessories, flexible/rigid
|
510(k) Number |
K013640 |
Device Name |
EG-3630UR, ULTRASUND VIDEO GASTROSCOPE |
Applicant |
PENTAX PRECISION INSTRUMENT CORP. |
30 RAMLAND RD. |
ORANGEBURG,
NY
10962
|
|
Applicant Contact |
PAUL SILVA |
Correspondent |
PENTAX PRECISION INSTRUMENT CORP. |
30 RAMLAND RD. |
ORANGEBURG,
NY
10962
|
|
Correspondent Contact |
PAUL SILVA |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 11/05/2001 |
Decision Date | 02/04/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|