PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD


Device Classification Name

tampon, menstrual, scented, deodorized

510(k) Number K111684
Device Name PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD
Applicant
PLAYTEX MANUFACTURING INC.
75 commerce drive
allendale, 
NJ 
07401

Applicant Contact pushpa rao
Correspondent
PLAYTEX MANUFACTURING INC.
75 commerce drive
allendale, 
NJ 
07401

Correspodent Contact pushpa rao
Regulation Number 884.5460
Classification Product Code
HIL  
Date Received 06/15/2011
Decision Date 02/03/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No