JOE LUB HELMET CONDOM


Device Classification Name

condom

510(k) Number K011378
Device Name JOE LUB HELMET CONDOM
Original Applicant
MARKETING SALES CONCEPTS, INC. (MSCI)
200 renaissance company
suite 111
atlanta, 
GA 
30308

Original Contact eric j arthur
Regulation Number 884.5300
Classification Product Code
HIS  
Date Received 05/03/2001
Decision Date 03/25/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

Type Abbreviated
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized