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510(k) K081191

TCM ENDO 20 by NOUVAG AG — Product Code EKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2008
Date Received
April 28, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Direct Drive, Ac-Powered
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

Other clearances by NOUVAG AG

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  • K071588 — DISPENSER DP 20 (November 26, 2007)
  • K042822 — TCM ENDO V, MODEL 1534 (December 22, 2004)
  • K042943 — NOUVAG AG - VACUSON 40 AND VACUSON 60 (December 17, 2004)
  • K042434 — MICRO-MOTORSYSTEMS MD20, SEM2, HIGHSURG 20 & DT55 (November 3, 2004)
  • K022505 — CONTRA-ANGLE, MODELS 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, (October 1, 2003)
  • K013185 — TCM ENDO III (November 28, 2001)
  • K000710 — MD 10, SEM, SM 12, CBM (May 11, 2000)
  • K981679 — TCM 3000 AND TCM ENDO (February 9, 1999)
  • K954722 — MICRO-DISPENSER 7000 & MICRODISPENSER 8000 (January 16, 1996)

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