Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K944414 |
Device Name |
DEKALB |
Applicant |
ENDOTEC, INC. |
6550A BEST FRIEND RD. |
NORCROSS,
GA
30071
|
|
Applicant Contact |
FREDDIE P ANDRIENI |
Correspondent |
ENDOTEC, INC. |
6550A BEST FRIEND RD. |
NORCROSS,
GA
30071
|
|
Correspondent Contact |
FREDDIE P ANDRIENI |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 09/08/1994 |
Decision Date | 09/27/1994 |
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
|
|
|