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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name chamber, hyperbaric
510(k) Number K951044
Device Name SYSTEM ONE HYPERBARIC CHAMBER
Applicant
NTH SYSTEMS, INC.
1208 SAFARI
SAN ANTONIO,  TX  78216
Applicant Contact PAUL RENEAU
Correspondent
NTH SYSTEMS, INC.
1208 SAFARI
SAN ANTONIO,  TX  78216
Correspondent Contact PAUL RENEAU
Regulation Number868.5470
Classification Product Code
CBF  
Date Received03/07/1995
Decision Date 01/25/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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