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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 K920948
Device Name TOPICAL SACRAL HYPERBARIC OXYGEN CHAMBER
Applicant
Topox Therapeuutic Rentals, Inc.
45 W. St.
Suite 2
North Attleboro,  MA  02703
Applicant Contact LYNNE ARONSON
Correspondent
Topox Therapeuutic Rentals, Inc.
45 W. St.
Suite 2
North Attleboro,  MA  02703
Correspondent Contact LYNNE ARONSON
Regulation Number878.5650
Classification Product Code
KPJ  
Date Received03/02/1992
Decision Date 08/11/1992
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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