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510(k) K052798

CAPSULS, MODELS 2003-PUR8C, 2004-PVC8C by Isovac Products, LLC — Product Code LGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2006
Date Received
October 3, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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Other clearances for product code LGN

  • K790658 — AIRCRAFT TRANSIT ISOLATOR MODEL 121 (July 3, 1979)