KEGELMASTER 2000


Device Classification Name

perineometer

510(k) Number K023305
Device Name KEGELMASTER 2000
Original Applicant
KEGELMASTER 2000 LTD.
p.o. box 4341
crofton, 
MD 
21114

Original Contact yolanda smith
Regulation Number 884.1425
Classification Product Code
HIR  
Date Received 10/03/2002
Decision Date 12/26/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No