ORTHO ALL-FLEX DIAPHRAGM


Device Classification Name

diaphragm, contraceptive (and accessories)

510(k) Number K080040
Device Name ORTHO ALL-FLEX DIAPHRAGM
Applicant
JOHNSON & JOHNSON PRODUTOS PROFISSIONAIS LTDA.
220 river road
claremont, 
NH 
03743 -5647

Applicant Contact william greenrose
Correspondent
JOHNSON & JOHNSON PRODUTOS PROFISSIONAIS LTDA.
220 river road
claremont, 
NH 
03743 -5647

Correspodent Contact william greenrose
Regulation Number 884.5350
Classification Product Code
HDW  
Date Received 01/07/2008
Decision Date 08/25/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No