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510(k) K904682

VISTEK ELECTRONIC CONTROLLER by Vistek Corp. — Product Code GEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1990
Date Received
October 15, 1990
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

Other clearances by Vistek Corp.

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  • K843806 — VIS-1000 VIDEO SYSTEM (December 12, 1984)

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  • K971782 — BONE AND MARROW COLLECTION SYSTEM KIT (July 29, 1997)
  • K971268 — BONE & MARROW CLLECTION SYSTEM (July 3, 1997)
  • K964252 — ORTHOCHUCK (May 27, 1997)
  • K970530 — ANSPACH LUBRICATING SYSTEM II (May 5, 1997)
  • K964073 — BME BONE DRILL BITS (November 14, 1996)