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510(k) K970953

E-TYPE SPEED REDUCER CONTRA ANGLE by Nsk Nakanishi, Inc. — Product Code KMW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1997
Date Received
March 17, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Rotary Bone Cutting
Device Class
Class II
Regulation Number
872.4120
Review Panel
DE
Submission Type

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  • K980162 — MACH-SIGMA HANDPIECE, ULTRAPUSH (June 5, 1998)
  • K972924 — SURGIC II IMPLANT CONTROL UNIT (October 30, 1997)
  • K972569 — E-TYPE SPEED INCREASER CONTRA ANGLE, EXTERNAL IRRIGATION, INTERNAL IRRIGATION (October 8, 1997)
  • K971774 — NSK PUSH-BUTTON MIDWEST REPLACEMENT TURBINE:FOR QUIETAIR AND TRADITION (June 20, 1997)
  • K962542 — AIR MOTOR HANDPIECE TN-102 (September 24, 1996)

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