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510(k) K841711

MAC LEE SITZ BATH by Mac Lee Medical Products — Product Code KTC

K841711 is an FDA 510(k) premarket notification submitted by Mac Lee Medical Products for the device "MAC LEE SITZ BATH". The FDA issued a decision of Substantially Equivalent on May 7, 1984. The device falls under product code KTC (Bath, Sitz, Nonpowered), a Class I device regulated under 21 CFR 890.5125. Mac Lee Medical Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 1984
Date Received
April 24, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bath, Sitz, Nonpowered
Device Class
Class I
Regulation Number
890.5125
Review Panel
PM
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)
  • K864781 — MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 20ML/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)
  • 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 KTC

  • K912179 — THE SPRITZ BATH (August 28, 1991)
  • K890085 — SIT-N-BATHE SITZ BATH (February 13, 1989)
  • K862600 — SITZ BATH (July 18, 1986)
  • K851309 — ABCO PLASTIC UTENSILS (July 1, 1985)
  • K831762 — SITZ BATH, SINGLE PATIENT USE #8100 (June 24, 1983)
  • K800958 — PERSONAL SITZ BATH KIT (May 2, 1980)

FDA data resources