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510(k) K000031

AQUANET, MODEL EC 2000 by Prime Pacific Health Innovations Corporation — Product Code KPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 2001
Date Received
January 5, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colonic Irrigation System
Device Class
Class II
Regulation Number
876.5220
Review Panel
GU
Submission Type

Other clearances by Prime Pacific Health Innovations Corporation

  • K050112 — PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117 (March 15, 2005)

Other clearances for product code KPL

  • K201861 — Bio Fluff System (March 2, 2022)
  • K180800 — Colonic Plus Regular, Small, and Straight Shape Hydrokit (June 1, 2018)
  • K152834 — Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop (August 10, 2016)
  • K150381 — AQUA CLEANSE (September 11, 2015)
  • K131852 — HC-1 AND HC-1 CLASSIC (April 17, 2014)
  • K094022 — THE WATER LILY (June 11, 2010)
  • K071057 — COLONIC & ENEMA NOZZLE (October 5, 2007)
  • K051344 — COLONIC AND ENEMA NOZZLE (August 18, 2005)
  • K050992 — CONMED IRRIGATION NOZZLE (July 14, 2005)
  • K050112 — PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117 (March 15, 2005)