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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 K102831
Device Name RSI 4200
Applicant
Reimers Systems, Inc.
8210-D Cinderbed Rd.
Lorton,  VA  22079
Applicant Contact NAYIL ALAM
Correspondent
Reimers Systems, Inc.
8210-D Cinderbed Rd.
Lorton,  VA  22079
Correspondent Contact NAYIL ALAM
Regulation Number868.5470
Classification Product Code
CBF  
Date Received09/29/2010
Decision Date 08/19/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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