Device Classification Name |
laparoscope, general & plastic surgery
|
510(k) Number |
K945297 |
Device Name |
INFRA VISION IMAGING SYSTEM |
Applicant |
GABRIEL MEDICAL, INC. |
2014 WEST PINHOOK RD., #604 |
LAFAYETTE,
LA
70508
|
|
Applicant Contact |
MARY M MCNAMARA |
Correspondent |
GABRIEL MEDICAL, INC. |
2014 WEST PINHOOK RD., #604 |
LAFAYETTE,
LA
70508
|
|
Correspondent Contact |
MARY M MCNAMARA |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 10/31/1994 |
Decision Date | 12/20/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|