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510(k) K021813

HYDROCISION GENERAL SURGERY FLUIDJET SYSTEM by Hydrocision, Inc. — Product Code FQH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2003
Date Received
June 3, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lavage, Jet
Device Class
Class II
Regulation Number
880.5475
Review Panel
HO
Submission Type

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  • K041233 — ARTHROJET XT (July 28, 2004)
  • K032529 — HYDROCISION ARTHROJET SYSTEM WITH CAUTERY, TURBOBURR AND CURETTE, MODELS 51300, (September 16, 2003)
  • K020688 — HYDROCISION ARTHOJET SYSTEM WITH CAUTERY AND TURBOBURR (April 3, 2002)
  • K011612 — MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM (June 22, 2001)
  • K002764 — HYDROCISION ARTHROJET SYSTEM WITH CAUTERY AND BURR (November 24, 2000)
  • K991383 — HYDROCISION DEBDRIDEMENT SYSTEM (March 31, 2000)
  • K993009 — HYDROCISION ARTHROJET SYSTEM WITH CAUTERY (October 25, 1999)

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