| Device Classification Name |
Pad, Menstrual, Unscented
|
| 510(k) Number |
K933879 |
| Device Name |
PADS MENSTRUAL, UNTREAT DEODORIZED, VARIOUS SIZES |
| Applicant |
| Universal Health Care Products Canada, Inc. |
| 870 Ellingham St., Pt.e |
| Claire |
|
Quebec H9r 3s4,
CA
|
|
| Applicant Contact |
DAVE LOCKHART |
| Correspondent |
| Universal Health Care Products Canada, Inc. |
| 870 Ellingham St., Pt.e |
| Claire |
|
Quebec H9r 3s4,
CA
|
|
| Correspondent Contact |
DAVE LOCKHART |
| Regulation Number | 884.5435 |
| Classification Product Code |
|
| Date Received | 08/09/1993 |
| Decision Date | 03/24/1994 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Obstetrics/Gynecology
|
| 510k Review Panel |
Obstetrics/Gynecology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|