Device Classification Name |
Tampon, Menstrual, Scented, Deodorized
|
510(k) Number |
K070745 |
Device Name |
MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK TAMPONS |
Applicant |
PLAYTEX PRODUCTS, INC. |
804 WALKER RD. |
DOVER,
DE
19904
|
|
Applicant Contact |
KEITH EDGETT |
Correspondent |
PLAYTEX PRODUCTS, INC. |
804 WALKER RD. |
DOVER,
DE
19904
|
|
Correspondent Contact |
KEITH EDGETT |
Regulation Number | 884.5460
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/19/2007 |
Decision Date | 04/13/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|