NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM


Device Classification Name

condom

510(k) Number K002393
Device Name NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM
Original Applicant
INNOLATEX SDN. BHD
no 16, jalan bulan u5/5
bandar pinggiran subang,
shah alam,selangor darul ehsan, 

MY

Original Contact chang ah-kau
Regulation Number 884.5300
Classification Product Code
HIS  
Date Received 08/07/2000
Decision Date 12/19/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

Type Abbreviated
Reviewed by Third Party No

Combination Product

No