MAXIM PLASTIC APPLICATOR & NON-APPLICATOR TAMPONS


Device Classification Name

tampon, menstrual, unscented

510(k) Number K080775
Device Name MAXIM PLASTIC APPLICATOR & NON-APPLICATOR TAMPONS
Applicant
TOSAMA D.D.
saranoviceva cesta 035
vir, domzale, 

SI

1230

Applicant Contact antonija vidensek
Regulation Number 884.5470
Classification Product Code
HEB  
Date Received 03/19/2008
Decision Date 09/10/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No