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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chamber, Oxygen, Topical, Extremity
510(k) Number K861593
Device Name TOPICAL HYPERBARIC OXYGEN CHAMBER
Applicant
Stephenson Industries, Inc.
P. O. Box 1000
Farmingdale,  NJ  07727
Applicant Contact R. A LASLEY
Correspondent
Stephenson Industries, Inc.
P. O. Box 1000
Farmingdale,  NJ  07727
Correspondent Contact R. A LASLEY
Regulation Number878.5650
Classification Product Code
KPJ  
Date Received04/29/1986
Decision Date 05/12/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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