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510(k) K991383

HYDROCISION DEBDRIDEMENT SYSTEM by Hydrocision, Inc. — Product Code FQH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2000
Date Received
April 21, 1999
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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  • K032529 — HYDROCISION ARTHROJET SYSTEM WITH CAUTERY, TURBOBURR AND CURETTE, MODELS 51300, (September 16, 2003)
  • K021813 — HYDROCISION GENERAL SURGERY FLUIDJET SYSTEM (May 9, 2003)
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  • K011612 — MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM (June 22, 2001)
  • K002764 — HYDROCISION ARTHROJET SYSTEM WITH CAUTERY AND BURR (November 24, 2000)
  • K993009 — HYDROCISION ARTHROJET SYSTEM WITH CAUTERY (October 25, 1999)

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