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510(k) K963777

HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100 by Stephenson Industries, Inc. — Product Code KPJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1997
Date Received
September 20, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chamber, Oxygen, Topical, Extremity
Device Class
Class II
Regulation Number
878.5650
Review Panel
SU
Submission Type

Other clearances by Stephenson Industries, Inc.

  • K861593 — TOPICAL HYPERBARIC OXYGEN CHAMBER (May 12, 1986)
  • K861101 — THE NEW FLEXIBLE COLLAPSIBLE CHAMBER (May 6, 1986)
  • K853971 — REGULATOR-INHALATOR SYSTEM (December 9, 1985)

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  • K022028 — VX-400 TOPICAL HYPERBARIC OXYGEN CHAMBER (December 17, 2002)