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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 K092991
Device Name O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING)
Applicant
Environmental Tectonics Corp.
125 James Way
Southampton,  PA  18966
Applicant Contact GENE DAVIS
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact DANIEL W LEHTONEN
Regulation Number868.5470
Classification Product Code
CBF  
Date Received09/28/2009
Decision Date 08/13/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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