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510(k) K933593

LUMINOUS 150 FIBEROPTIC ILLUMINATOR by Progressive Dynamics, Inc. — Product Code HBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 1993
Date Received
July 26, 1993
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)
  • K921866 — LUMINOUS 250 FIBEROPTIC ILLUMINATOR (July 8, 1992)
  • K914382 — LIFE-AIR 1000 HYPOTHERMIC TREATMENT SYSTEM (April 21, 1992)
  • K914383 — LIFE-AIR 1000 PATIENT WARMING COVERS (March 30, 1992)

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