Device Classification Name |
light source, fiberoptic, routine
|
510(k) Number |
K131226 |
Device Name |
NOVAPROBE LED LIGHT SOURCE |
Applicant |
NOVAPROBE INCORPORATED |
2333W. MAIN STREET SUITE 210 |
LANSDALE,
PA
19446
|
|
Applicant Contact |
MANISH INGLE |
Correspondent |
NOVAPROBE INCORPORATED |
2333W. MAIN STREET SUITE 210 |
LANSDALE,
PA
19446
|
|
Correspondent Contact |
MANISH INGLE |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/30/2013 |
Decision Date | 07/24/2014 |
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
|
|
|