NATURAL ORDINARY RIBBED,DOTTED,AND CONTOURED (MALE RUBBER LATEX CONDOM, LUBRICATED W/SILICONE OIL


codes

Device Classification Name

condom

510(k) Number K002060
Device Name NATURAL ORDINARY RIBBED,DOTTED,AND CONTOURED (MALE RUBBER LATEX CONDOM, LUBRICATED W/SILICONE OIL
Original Applicant
DONGKUK TECHCO RUBBER INDUSTRIES
3 penang st.
7th fl., mayban trust bldg.
penang, 

MY

10200

Original Contact peter park
Regulation Number 884.5300
Classification Product Code
HIS  
Date Received 07/06/2000
Decision Date 09/07/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

Type Abbreviated
Reviewed by Third Party No

Combination Product

No