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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chair, Ophthalmic, Ac-Powered
510(k) Number K863728
Device Name THE ERGOSYSTEM CHAIR
Applicant
Charles D. Bell, Inc.
1214 Rte. 130
Westville,  NJ  08093
Applicant Contact BELL, JR
Correspondent
Charles D. Bell, Inc.
1214 Rte. 130
Westville,  NJ  08093
Correspondent Contact BELL, JR
Regulation Number886.1140
Classification Product Code
HME  
Date Received09/23/1986
Decision Date 10/31/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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