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510(k) K854595

P.A. MEDICAL VAGINAL IRRIGATION SET #1130 by Pa Medical Corp. — Product Code HED

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1986
Date Received
November 18, 1985
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 by Pa Medical Corp.

  • K910903 — INFLATE-A-CUFF #7014 (May 8, 1991)
  • K871449 — ONCOLOGY SPT SYS #MS-C10 MEDICATION RESERVOIR BAG (June 17, 1987)
  • K860084 — PRESSURE INFUSOR #1900 (March 18, 1986)
  • K853309 — P.A. ENTERAL FEEDING BAG 1100 (August 27, 1985)

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)
  • 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)
  • K800957 — DOUCHE UNIT-1500 ML DISP. CONTAINER (July 14, 1980)