PH BUFFERING PLASTIC APPLICATOR TAMPON


Device Classification Name

tampon, menstrual, unscented

510(k) Number K030474
Device Name PH BUFFERING PLASTIC APPLICATOR TAMPON
Applicant
ROSTAM LTD.
555 13th st. nw
washington, 
DC 
20004 -1109

Applicant Contact jonathan s kahan
Correspondent
ROSTAM LTD.
555 13th st. nw
washington, 
DC 
20004 -1109

Correspodent Contact jonathan s kahan
Regulation Number 884.5470
Classification Product Code
HEB  
Date Received 02/12/2003
Decision Date 05/28/2004
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

Yes