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510(k) K973035

VIOLA II DENTAL CAMERA SYSTEM by Innovative Medical Systems, Inc. — Product Code EIA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 1997
Date Received
August 14, 1997
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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  • K880745 — LX-100 SLIDE STAINER (April 27, 1988)
  • K853938 — LX 300 TISSUE PROCESSOR (October 10, 1985)

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