UNIDUS MALE LATEX CONDOM (YELLOW, PINK, GREEN & BLACK)


Device Classification Name

condom

510(k) Number K023129
Device Name UNIDUS MALE LATEX CONDOM (YELLOW, PINK, GREEN & BLACK)
Original Applicant
UNIDUS CORP.
1219 little creek rd.
durham, 
NC 
27713

Original Contact eli j carter
Regulation Number 884.5300
Classification Product Code
HIS  
Date Received 09/19/2002
Decision Date 12/13/2002
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