MULTIPLE, MALE LATEX CONDOM [52MM OR 56MM NOMINAL WIDTH WITH SMOOTH OR DOTTED OR RIBBED OR 3 IN 1 (DOTTED/RIBBED/CONTOUR


Device Classification Name

condom

510(k) Number K023333
Device Name MULTIPLE, MALE LATEX CONDOM [52MM OR 56MM NOMINAL WIDTH WITH SMOOTH OR DOTTED OR RIBBED OR 3 IN 1 (DOTTED/RIBBED/CONTOUR
Original Applicant
PLEASURE LATEX PRODUCTS SDN. BHD.
lot 1365, 17th miles, jalan
sungai sembilang
jeram, selangor, 

MY

45800

Original Contact koi-yong lim
Regulation Number 884.5300
Classification Product Code
HIS  
Subsequent Product Code
LTZ  
Date Received 10/07/2002
Decision Date 06/23/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

statement

statement

Type Abbreviated
Reviewed by Third Party No

Combination Product

Yes