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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 K853150
Device Name RELIANCE 6100
Applicant
F. & F. KOENIGKRAMER
96 CALDWELL DR.
CINCINNATI,  OH  45216
Applicant Contact SEMMELMAN
Correspondent
F. & F. KOENIGKRAMER
96 CALDWELL DR.
CINCINNATI,  OH  45216
Correspondent Contact SEMMELMAN
Regulation Number886.1140
Classification Product Code
HME  
Date Received07/29/1985
Decision Date 09/05/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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