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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stand, instrument, ac-powered, ophthalmic
510(k) Number K931839
Device Name ROTA SYSTEM XL
Applicant
ROTA SYSTEMS MEDFURNITURE, INC.
519 N. BUCKNER
P.O. BOX 361
DERBY,  KS  67037
Applicant Contact SAM R MYERS
Correspondent
ROTA SYSTEMS MEDFURNITURE, INC.
519 N. BUCKNER
P.O. BOX 361
DERBY,  KS  67037
Correspondent Contact SAM R MYERS
Regulation Number886.1860
Classification Product Code
HMF  
Date Received04/13/1993
Decision Date 11/22/1993
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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