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510(k) K781207

DOUCHE KIT, SOMETHING PERSONAL by Chatten Drug & Chemical Co. — Product Code HED

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1978
Date Received
July 14, 1978
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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  • K854595 — P.A. MEDICAL VAGINAL IRRIGATION SET #1130 (January 13, 1986)
  • K841710 — MAC LEE VAGINAL IRRIGATOR (June 19, 1984)
  • K831667 — FEMININE HYGIENE DEVICE (September 12, 1983)
  • K800956 — DOUCH TRAY-DISPOSABLE VAGINAL TRAY W/BEN (October 3, 1980)
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