HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100— 510(k) K963777

Name: FDA 510(k) clearance K963777
Creator: U.S. Food and Drug Administration
Published: 1997-07-28

Substantially Equivalent

Stephenson Industries, Inc.

FDA 510(k) clearance K963777 for HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100, Substantially Equivalent on 1997-07-28. Applicant: Stephenson Industries, Inc.. Device class: 2.

Clearance details

Applicant: Stephenson Industries, Inc.
Product code: Code KPJ
Device class: Class 2
Regulation: 21 CFR 878.5650
Advisory panel: General, Plastic Surgery
Date received: 1996-09-20
Decision date: 1997-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Point Pleasant, NJ, US

Download summary PDF View on FDA.gov ↗

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