Device Classification Name |
colonoscope and accessories, flexible/rigid
|
510(k) Number |
K093037 |
Device Name |
PENTEX EC-3890LI |
Applicant |
PENTAX MEDICAL COMPANY |
102 CHESTNUT RIDGE RD. |
MONTVALE,
NJ
07645 -1856
|
|
Applicant Contact |
LISA LANCIA |
Correspondent |
PENTAX MEDICAL COMPANY |
102 CHESTNUT RIDGE RD. |
MONTVALE,
NJ
07645 -1856
|
|
Correspondent Contact |
LISA LANCIA |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 09/29/2009 |
Decision Date | 12/28/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|