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510(k) K841710

MAC LEE VAGINAL IRRIGATOR by Mac Lee Medical Products — Product Code HED

K841710 is an FDA 510(k) premarket notification submitted by Mac Lee Medical Products for the device "MAC LEE VAGINAL IRRIGATOR". The FDA issued a decision of Substantially Equivalent on June 19, 1984. The device falls under product code HED (Douche Apparatus, Vaginal, Therapeutic), a Class I device regulated under 21 CFR 884.5900. Mac Lee Medical Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 1984
Date Received
April 24, 1984
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 Mac Lee Medical Products

  • K872953 — DISPOSABLE I.V. ADMINISTRATION SET (January 6, 1988)
  • K872006 — DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF (November 17, 1987)
  • K870995 — SCALP VEIN SET (July 31, 1987)
  • K864779 — MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 50ML/CC (December 29, 1986)
  • K864778 — MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 30ML/CC (December 29, 1986)
  • K864777 — MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 3ML/CC (December 29, 1986)
  • K864781 — MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 20ML/CC (December 29, 1986)
  • K864782 — MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 10ML/CC (December 23, 1986)
  • K864780 — MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 1ML/CC (December 23, 1986)
  • K864783 — MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 5ML/CC (December 23, 1986)

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)
  • 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)

FDA data resources