GYNEFLEX


Device Classification Name

perineometer

510(k) Number K021115
Device Name GYNEFLEX
Original Applicant
NAISSANCE HOLDINGS, LC
800 connecticut avenue, n.w.
suite 500
washington, 
DC 
20006

Original Contact nancy e taylor
Regulation Number 884.1425
Classification Product Code
HIR  
Date Received 04/08/2002
Decision Date 12/20/2002
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