Device Classification Name |
pad, menstrual, reusable
|
510(k) Number |
K010986 |
Device Name |
LUNAPADS |
Applicant |
LUNAPADS INTERNATIONAL PRODUCTS LTD |
207 WEST 6TH AVENUE |
VANCOUVER BC,
CA
V5Y 1K7
|
|
Applicant Contact |
SUZANNE SIEMENS |
Correspondent |
LUNAPADS INTERNATIONAL PRODUCTS LTD |
207 WEST 6TH AVENUE |
VANCOUVER BC,
CA
V5Y 1K7
|
|
Correspondent Contact |
SUZANNE SIEMENS |
Regulation Number | 884.5435
|
Classification Product Code |
|
Date Received | 04/02/2001 |
Decision Date | 06/13/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|