Device Classification Name |
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
|
510(k) Number |
K895855 |
Device Name |
PHOENIX |
Applicant |
MEDICAL AND SCIENTIFIC ENTERPRISES, INC. |
29 WALL ST. |
FOXBORO,
MA
02035
|
|
Applicant Contact |
PAUL NARDELLA |
Correspondent |
MEDICAL AND SCIENTIFIC ENTERPRISES, INC. |
29 WALL ST. |
FOXBORO,
MA
02035
|
|
Correspondent Contact |
PAUL NARDELLA |
Regulation Number | 876.4300
|
Classification Product Code |
|
Date Received | 10/02/1989 |
Decision Date | 01/22/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|