Device Classification Name |
implant, eye sphere
|
510(k) Number |
K960859 |
Device Name |
MEDPOR OCULAR PEG SYSTEM AND ACCESSORIES |
Applicant |
POREX TECHNOLOGIES CORP. OF GEORGIA |
500 BOHANNON RD. |
FAIRBURN,
GA
30213
|
|
Applicant Contact |
HOWARD MERCER, PH.D. |
Correspondent |
POREX TECHNOLOGIES CORP. OF GEORGIA |
500 BOHANNON RD. |
FAIRBURN,
GA
30213
|
|
Correspondent Contact |
HOWARD MERCER, PH.D. |
Regulation Number | 886.3320
|
Classification Product Code |
|
Date Received | 03/01/1996 |
Decision Date | 05/29/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|