Device Classification Name |
laparoscope, general & plastic surgery
|
510(k) Number |
K042741 |
Device Name |
EC-3870CILK, CONFOCAL VIDEO COLONOSCOPE |
Applicant |
PENTAX MEDICAL COMPANY |
102 CHESTNUT RIDGE ROAD |
MONTVALE,
NJ
07645
|
|
Applicant Contact |
PAUL SILVA |
Correspondent |
TUV RHEINLAND OF NORTH AMERICA, INC. |
12 COMMERCE RD. |
NEWTON,
CT
06470
|
|
Correspondent Contact |
TAMAS BORSAI |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/04/2004 |
Decision Date | 10/19/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|