| Device Classification Name |
Applicator, Ocular Pressure
|
| 510(k) Number |
K840004 |
| Device Name |
WEE BAG O'MERCURY |
| Applicant |
| Surgi-Quip Inc.U |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Correspondent |
| Surgi-Quip Inc.U |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Regulation Number | 886.4610 |
| Classification Product Code |
|
| Date Received | 01/04/1984 |
| Decision Date | 03/22/1984 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Ophthalmic
|
| 510k Review Panel |
Ophthalmic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|