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510(k) K050112

PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117 by Prime Pacific Health Innovations Corporation — Product Code KPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2005
Date Received
January 18, 2005
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

  • K000031 — AQUANET, MODEL EC 2000 (September 10, 2001)

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  • K150381 — AQUA CLEANSE (September 11, 2015)
  • K131852 — HC-1 AND HC-1 CLASSIC (April 17, 2014)
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  • K071057 — COLONIC & ENEMA NOZZLE (October 5, 2007)
  • K051344 — COLONIC AND ENEMA NOZZLE (August 18, 2005)
  • K050992 — CONMED IRRIGATION NOZZLE (July 14, 2005)
  • K033149 — ULTIMATE PROFESSIONAL CONTINUOUS FLOW COLONIC SYSTEM (March 23, 2004)