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510(k) K011612

MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM by Hydrocision, Inc. — Product Code FQH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2001
Date Received
May 25, 2001
Clearance Type
Special
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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  • K021813 — HYDROCISION GENERAL SURGERY FLUIDJET SYSTEM (May 9, 2003)
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  • 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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