Device Classification Name |
Sponge, Ophthalmic
|
510(k) Number |
K993883 |
Device Name |
M-PACT CORNEAL LIGHT SHIELD |
Applicant |
M-PACT CORP. |
1040 0CL PARKWAY, |
EUDORA,
KS
|
|
Applicant Contact |
AL BOEDEKER |
Correspondent |
M-PACT CORP. |
1040 0CL PARKWAY, |
EUDORA,
KS
|
|
Correspondent Contact |
AL BOEDEKER |
Regulation Number | 886.4790
|
Classification Product Code |
|
Date Received | 11/15/1999 |
Decision Date | 12/21/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|