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510(k) K945659

BLACKSTAR(TM) STAR SYSTEM by Xomed-Treace, Inc. — Product Code ERL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 1995
Date Received
November 17, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Device Class
Class II
Regulation Number
874.4250
Review Panel
EN
Submission Type

Other clearances by Xomed-Treace, Inc.

  • K940028 — ENDOSCOPE SHEATH (March 24, 1995)
  • K941407 — TYMPANOSTOMY (VENTILATION) TUBE (March 14, 1995)
  • K932771 — BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE (August 24, 1994)
  • K933672 — XOMED-TREACE SCOPESHEATH (July 18, 1994)
  • K934426 — NERVE INTEGRITY MONITOR-2 (NIM-2 XL) (May 13, 1994)
  • K933105 — XOMED-TREACE RIGID ROD LENS ENDOSCOPE (January 5, 1994)
  • K925640 — XOMED-TREACE EMG ENDOTRACHEAL TUBEEN (August 17, 1993)
  • K922880 — XOMED TREACE JET VENTILATION TUBE (April 15, 1993)
  • K923830 — XOMED-TREACE ALPHASCOPE (November 9, 1992)
  • K912753 — XOMED-TREACE POSITROL FOOTPEDAL SUCTION CONTROL (September 23, 1991)

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