UNIDUS MAGNUM MALE LATEX CONDOM


Device Classification Name

condom

510(k) Number K072747
Device Name UNIDUS MAGNUM MALE LATEX CONDOM
Applicant
UNIDUS CORP.
507 shallow creek road
tuscaloosa, 
AL 
35406

Applicant Contact claude l wright
Correspondent
UNIDUS CORP.
507 shallow creek road
tuscaloosa, 
AL 
35406

Correspodent Contact claude l wright
Regulation Number 884.5300
Classification Product Code
HIS  
Date Received 09/27/2007
Decision Date 11/15/2007
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