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510(k) K080117

PATIENT ISOLATION UNIT, MODEL G019-1000 by Gentex Corporation — Product Code LGM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 2009
Date Received
January 17, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chamber, Patient Isolation
Device Class
Class II
Regulation Number
880.5450
Review Panel
HO
Submission Type

Other clearances by Gentex Corporation

  • K800521 — THE LENS OR OMMI-GARD (March 12, 1980)
  • K772024 — RX LENS SERIES (November 9, 1977)

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