THAI NIPPON MALE LATEX CONDOM


Device Classification Name

condom

510(k) Number K081265
Device Name THAI NIPPON MALE LATEX CONDOM
Applicant
THAI NIPPON RUBBER INDUSTRY CO., LTD.
po box 12139
durham, 
NC 
27709

Applicant Contact eli j carter
Correspondent
THAI NIPPON RUBBER INDUSTRY CO., LTD.
po box 12139
durham, 
NC 
27709

Correspodent Contact eli j carter
Regulation Number 884.5300
Classification Product Code
HIS  
Date Received 05/05/2008
Decision Date 10/16/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No