| Device Classification Name |
Plug, Punctum
|
| 510(k) Number |
K021936 |
| Device Name |
MOIST PUNCTAL PLUG SYSTEM |
| Applicant |
| Moist Medical, Inc. |
| 2180 Wickersham Ln. |
|
Germantown,
TN
38139
|
|
| Applicant Contact |
GEORGE W MURRAY |
| Correspondent |
| Moist Medical, Inc. |
| 2180 Wickersham Ln. |
|
Germantown,
TN
38139
|
|
| Correspondent Contact |
GEORGE W MURRAY |
| Classification Product Code |
|
| Date Received | 06/12/2002 |
| Decision Date | 10/16/2002 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Ophthalmic
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|