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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chair, Positioning, Electric
510(k) Number K112944
Device Name FRESENIUS MEDICAL TREATMENT CHAIR T688 SERIES
Applicant
Fresenius Medical Care South Asia Pacific Pty , Ltd.
Level 17, 61 Lavender St.
Milsons Point,,  AU 2061
Applicant Contact RAM KAMATH
Correspondent
Fresenius Medical Care South Asia Pacific Pty , Ltd.
Level 17, 61 Lavender St.
Milsons Point,,  AU 2061
Correspondent Contact RAM KAMATH
Regulation Number890.3110
Classification Product Code
INO  
Date Received10/04/2011
Decision Date 12/30/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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