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510(k) K000736

LA JOIE by Goomi Ehwa, Inc. — Product Code HED

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2000
Date Received
March 7, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Douche Apparatus, Vaginal, Therapeutic
Device Class
Class I
Regulation Number
884.5900
Review Panel
OB
Submission Type

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  • K800956 — DOUCH TRAY-DISPOSABLE VAGINAL TRAY W/BEN (October 3, 1980)
  • K800954 — DOUCHE TRAY-DISPOS. VAGINAL TRAY W/POVID (October 3, 1980)
  • K800957 — DOUCHE UNIT-1500 ML DISP. CONTAINER (July 14, 1980)