UNDUS MALE LATEX CONDOM (WITH FLAVORING)


Device Classification Name

condom

510(k) Number K023176
Device Name UNDUS MALE LATEX CONDOM (WITH FLAVORING)
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 09/23/2002
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