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510(k) K984641

FLEXISCOPE OPTOMODUL by Schoelly Fiberoptic GmbH — Product Code EIA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 1999
Date Received
December 31, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Operative Dental
Device Class
Class I
Regulation Number
872.6640
Review Panel
DE
Submission Type

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