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510(k) K082455

RECTANGULAR MULTIPLACE HYPERBARIC CHAMBER by Gulf Coast Hyperbarics, Inc. — Product Code CBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2009
Date Received
August 26, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chamber, Hyperbaric
Device Class
Class II
Regulation Number
868.5470
Review Panel
AN
Submission Type

Other clearances by Gulf Coast Hyperbarics, Inc.

  • K011565 — INFANT OXYGEN TREATMENT HOOD (August 16, 2001)
  • K950957 — MULTIPLACE HYPERBARIC TREATMENT CHAMBER SYSTEM (June 2, 1995)

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