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510(k) K781207

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

K781207 is an FDA 510(k) premarket notification submitted by Chatten Drug & Chemical Co. for the device "DOUCHE KIT, SOMETHING PERSONAL". The FDA issued a decision of Substantially Equivalent on August 10, 1978. The device falls under product code HED (Douche Apparatus, Vaginal, Therapeutic), a Class I device regulated under 21 CFR 884.5900.

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

Other clearances for product code HED

  • K080200 — WATER WORKS DOUCHING DEVICE (July 10, 2008)
  • K030056 — WORRY-REMOVER IRRIGATOR (April 22, 2003)
  • K000736 — LA JOIE (August 8, 2000)
  • K902830 — PERI-BOTTLE (August 6, 1990)
  • K881216 — GENT-L-KARE VAGINAL IRRIGATION SET (June 7, 1988)
  • 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)
  • K800954 — DOUCHE TRAY-DISPOS. VAGINAL TRAY W/POVID (October 3, 1980)

FDA data resources