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510(k) K061297

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 2007
Date Received
May 9, 2006
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

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  • K063688 — SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE (January 16, 2007)
  • K052572 — ANSPACH KNOTLESS ANCHOR (December 5, 2005)

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