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510(k) K921866

LUMINOUS 250 FIBEROPTIC ILLUMINATOR by Progressive Dynamics, Inc. — Product Code HBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1992
Date Received
April 20, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Illuminator, Fiberoptic, Surgical Field
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

Other clearances by Progressive Dynamics, Inc.

  • K952329 — LIFE-AIR 1000 HYPOTHERMIC THERAPY SYSTEM (January 17, 1996)
  • K944688 — LUMINOUS 150 DUAL LAMPFIBEROPTIC ILLUMINATOR (November 1, 1994)
  • K933764 — LIFE-AIR 1000 PATIENT WARMING COVER (November 9, 1993)
  • K933593 — LUMINOUS 150 FIBEROPTIC ILLUMINATOR (October 28, 1993)
  • K914382 — LIFE-AIR 1000 HYPOTHERMIC TREATMENT SYSTEM (April 21, 1992)
  • K914383 — LIFE-AIR 1000 PATIENT WARMING COVERS (March 30, 1992)

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  • K922837 — S1500 XENON LIGHT SOURCE (November 3, 1992)