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510(k) K904106

SPA SHELL by Century Manufacturing Co. — Product Code ILJ

K904106 is an FDA 510(k) premarket notification submitted by Century Manufacturing Co. for the device "SPA SHELL". The FDA issued a decision of Substantially Equivalent on September 18, 1990. The device falls under product code ILJ (Bath, Hydro-Massage), a Class II device regulated under 21 CFR 890.5100. Century Manufacturing Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 1990
Date Received
September 6, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bath, Hydro-Massage
Device Class
Class II
Regulation Number
890.5100
Review Panel
PM
Submission Type

Other clearances by Century Manufacturing Co.

  • K912769 — PATIENT LIFT AND TRANSPORT (October 2, 1991)
  • K844872 — CENTURY SCALE (February 8, 1985)
  • K844871 — CENTURY SAF-LIFT SCALE (February 8, 1985)
  • K830633 — LIC TILT BED (March 10, 1983)
  • K811902 — CENTURY BIRTHING CHAIR (August 25, 1981)
  • K811897 — LIC TURNOVER BED (July 28, 1981)
  • K811900 — CENTURY SAF-LIFT & SAF-KARY (July 28, 1981)
  • K811899 — CENTURY LIFT TRANSFER SYSTEM (July 23, 1981)
  • K811901 — CENTURY BATHING SYSTEM (July 23, 1981)
  • K811904 — CENTURY HYDRO-SAN THERAPY TANK (July 20, 1981)

Other clearances for product code ILJ

  • K110994 — PARKER 500 (July 6, 2011)
  • K082951 — IMMERSION HYDROBATH (April 8, 2009)
  • K052479 — MBATH 1000 (60) (January 26, 2006)
  • K040772 — PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM (April 5, 2004)
  • K012061 — SUPERIOR BATH, MODEL 6300 (July 19, 2001)
  • K012057 — CASCADE BATH, MODEL 6900 (July 19, 2001)
  • K001079 — RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO (May 1, 2000)
  • K993872 — VANNA BATHING SYSTEM (February 16, 2000)
  • K992779 — A-2000 BATHING SYSTEMS; HYDROSONIC BATHIN SYSTEM (January 13, 2000)
  • K991184 — HYDROTONE-THERMAL CAPSULE SYSTEM (June 23, 1999)

FDA data resources