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510(k) K954470

SURGIMOTOR by W.O.M. World of Medicine GmbH — Product Code GEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 1995
Date Received
September 26, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Motor, Surgical Instrument, Ac-Powered
Device Class
Class I
Regulation Number
878.4820
Review Panel
SU
Submission Type

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Other clearances for product code GEY

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  • K970530 — ANSPACH LUBRICATING SYSTEM II (May 5, 1997)
  • K964073 — BME BONE DRILL BITS (November 14, 1996)