Device Classification Name |
tampon, menstrual, unscented
|
510(k) Number |
K881384 |
Device Name |
INTERLABIAL PAD |
Applicant |
XTRAMEDICS, INC. |
108 WILMOT RD., #203 |
DEERFIELD,
IL
60015
|
|
Applicant Contact |
JOHN PERRY |
Correspondent |
XTRAMEDICS, INC. |
108 WILMOT RD., #203 |
DEERFIELD,
IL
60015
|
|
Correspondent Contact |
JOHN PERRY |
Regulation Number | 884.5470
|
Classification Product Code |
|
Date Received | 04/01/1988 |
Decision Date | 02/09/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|