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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 K833539
Device Name DOWING OPHTHALMIC CHAIR AC-POWERED
Applicant
Vision Health Technology
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Vision Health Technology
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number886.1140
Classification Product Code
HME  
Date Received10/05/1983
Decision Date 03/05/1984
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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