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510(k) K040186

ANSPACH MRI SAFE SURGICAL DRILL SYSTEM by The Anspach Effort, Inc. — Product Code HBB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 2004
Date Received
January 27, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Motor, Drill, Pneumatic
Device Class
Class II
Regulation Number
882.4370
Review Panel
NE
Submission Type

Other clearances by The Anspach Effort, Inc.

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  • K133604 — ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS (January 10, 2014)
  • K131053 — ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM (December 31, 2013)
  • K113476 — ANSPACH DISSECTION TOOLS (December 16, 2011)
  • K082637 — CRANIAL PERFORATOR (December 22, 2008)
  • K080802 — EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, E (April 30, 2008)
  • K061297 — ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM (January 26, 2007)
  • K063688 — SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE (January 16, 2007)

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  • K150801 — Stryker Maestro Air Motors (May 22, 2015)
  • K101168 — LEGEND POWER ADAPTER MODEL: 6475000 (August 24, 2010)
  • K093361 — SYNTHES AIR PEN DRIVE (APD) SYSTEM (April 14, 2010)
  • K090112 — MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC (March 26, 2009)
  • K061297 — ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM (January 26, 2007)
  • K061725 — STRYKER ARIA PNEUMATIC SYSTEM (October 26, 2006)
  • K042974 — MEDICON VIPAIR HIGH SPEED SYSTEM (January 13, 2005)