WATER WORKS DOUCHING DEVICE


Device Classification Name

douche apparatus, vaginal, therapeutic

510(k) Number K080200
Device Name WATER WORKS DOUCHING DEVICE
Applicant
ABBOTT RESEARCH GROUP, INC.
49 plain street
north attleboro, 
MA 
02760

Applicant Contact rosina robinson
Correspondent
ABBOTT RESEARCH GROUP, INC.
49 plain street
north attleboro, 
MA 
02760

Correspodent Contact rosina robinson
Regulation Number 884.5900
Classification Product Code
HED  
Date Received 01/25/2008
Decision Date 07/10/2008
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