TWINLOTUS AND SHIELDS NATURAL RUBBER LATEX CONDOM


Device Classification Name

condom

510(k) Number K081413
Device Name TWINLOTUS AND SHIELDS NATURAL RUBBER LATEX CONDOM
Applicant
DAILIAN LATEX COMPANY, LTD.
no. 188 malan north street
shahekou district
dailian city, liaoning, 

CN

116021

Regulation Number 884.5300
Classification Product Code
HIS  
Date Received 05/20/2008
Decision Date 10/24/2008
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