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510(k) K092329

SOPIX 2 by Sopro — Product Code MUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 2010
Date Received
August 4, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Extraoral Source, Digital
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type

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  • K082796 — SOPRO 184 CAMERA (April 1, 2009)
  • K080122 — SOPRO 670 ARTHROSCOPIC PUMP (July 11, 2008)
  • K070783 — SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR (December 13, 2007)
  • K072912 — SOPRO 225 DUAL HALOGEN LIGHT SOURCE (November 16, 2007)
  • K070102 — SOPRO 162 CAMERA (February 20, 2007)
  • K031593 — SOPRO 61D (September 16, 2003)

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