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510(k) K935945

ROTA DATAMATE I by Rota Systems,Inc. — Product Code HMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 1994
Date Received
December 13, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stand, Instrument, Ac-Powered, Ophthalmic
Device Class
Class I
Regulation Number
886.1860
Review Panel
OP
Submission Type

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