Device Classification Name |
sponge, ophthalmic
|
510(k) Number |
K982599 |
Device Name |
THE FREMSTAD RING |
Applicant |
OPHTHALMIC SOLUTIONS, LLC. |
2179 NORTHLAKE PKWY., BLDG. 5 |
SUITE 115 |
TUCKER,
GA
30084
|
|
Applicant Contact |
DARIA A FREMSTAD |
Correspondent |
OPHTHALMIC SOLUTIONS, LLC. |
2179 NORTHLAKE PKWY., BLDG. 5 |
SUITE 115 |
TUCKER,
GA
30084
|
|
Correspondent Contact |
DARIA A FREMSTAD |
Regulation Number | 886.4790
|
Classification Product Code |
|
Date Received | 07/27/1998 |
Decision Date | 02/16/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|