LATEX CONDOM AND LATEX CONDOM LUBRICATED WITH NONOXYNOL-9


Device Classification Name

condom

510(k) Number K024324
Device Name LATEX CONDOM AND LATEX CONDOM LUBRICATED WITH NONOXYNOL-9
Original Applicant
GLOBAL PROTECTION CORP.
12 channel st.
boston, 
MA 
02210

Original Contact davin t wedel
Regulation Number 884.5300
Classification Product Code
HIS  
Date Received 12/26/2002
Decision Date 03/25/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

statement

statement

Type Abbreviated
Reviewed by Third Party No

Combination Product

No