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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 K935945
Device Name ROTA DATAMATE I
Applicant
Rota Systems,Inc.
519 N. Buckner
P.O. Box 361
Derby,  KS  67037
Applicant Contact SAM R MYERS
Correspondent
Rota Systems,Inc.
519 N. Buckner
P.O. Box 361
Derby,  KS  67037
Correspondent Contact SAM R MYERS
Regulation Number886.1860
Classification Product Code
HMF  
Date Received12/13/1993
Decision Date 04/19/1994
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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