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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact ROSINA ROBINSON
Regulation Number884.5900
Classification Product Code
HED  
Date Received01/25/2008
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
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