Device Classification Name |
Depressor, Orbital
|
510(k) Number |
K951702 |
Device Name |
FMS HIGH FLOW ARTHRO-SHEATH |
Applicant |
FUTURE MEDICAL SYSTEMS, INC. |
205 EAST 63RD ST. |
SUITE 7A |
NEW YORK CITY,
NY
10021
|
|
Applicant Contact |
PATRICK JANIN |
Correspondent |
FUTURE MEDICAL SYSTEMS, INC. |
205 EAST 63RD ST. |
SUITE 7A |
NEW YORK CITY,
NY
10021
|
|
Correspondent Contact |
PATRICK JANIN |
Regulation Number | 886.4350
|
Classification Product Code |
|
Date Received | 04/12/1995 |
Decision Date | 05/12/1995 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|