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FDA 510(k) Application Details - K080200
Device Classification Name
Douche Apparatus, Vaginal, Therapeutic
More FDA Info for this Device
510(K) Number
K080200
Device Name
Douche Apparatus, Vaginal, Therapeutic
Applicant
ABBOTT RESEARCH GROUP, INC.
49 PLAIN STREET
NORTH ATTLEBORO, MA 02760 US
Other 510(k) Applications for this Company
Contact
ROSINA ROBINSON
Other 510(k) Applications for this Contact
Regulation Number
884.5900
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Classification Product Code
HED
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/25/2008
Decision Date
07/10/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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