Device Classification Name |
Endoilluminator
|
510(k) Number |
K952580 |
Device Name |
GAMP & ASSOCIATES DISPOSABLE BARE END FIBER |
Applicant |
GAMP & ASSOC. |
3237 HAAS |
BRIDGETON,
MO
63044
|
|
Applicant Contact |
JAMES TAYLOR |
Correspondent |
GAMP & ASSOC. |
3237 HAAS |
BRIDGETON,
MO
63044
|
|
Correspondent Contact |
JAMES TAYLOR |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 06/05/1995 |
Decision Date | 09/01/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|