Device Classification Name |
forceps, ophthalmic
|
510(k) Number |
K850119 |
Device Name |
PHARMASEAL EYE PREP TRAY |
Applicant |
AMERICAN PHARMASEAL DIV. AHSC |
1015 GRANDVIEW |
P.O. BOX 1300 |
GLENDALE,
CA
91209
|
|
Applicant Contact |
LARRY W GETLIN |
Correspondent |
AMERICAN PHARMASEAL DIV. AHSC |
1015 GRANDVIEW |
P.O. BOX 1300 |
GLENDALE,
CA
91209
|
|
Correspondent Contact |
LARRY W GETLIN |
Regulation Number | 886.4350
|
Classification Product Code |
|
Date Received | 01/14/1985 |
Decision Date | 05/09/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|