Device Classification Name |
Laser, Ophthalmic
|
510(k) Number |
K910532 |
Device Name |
URAM OPHTHALMIC LASER ENDOSCOPE |
Applicant |
MARTIN S. KNOPF ASSOC., INC. |
28 MARIGOLD LN. |
MARLBORO,
NJ
07746
|
|
Applicant Contact |
MARTIN S KNOPF |
Correspondent |
MARTIN S. KNOPF ASSOC., INC. |
28 MARIGOLD LN. |
MARLBORO,
NJ
07746
|
|
Correspondent Contact |
MARTIN S KNOPF |
Regulation Number | 886.4390
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/08/1991 |
Decision Date | 05/28/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|