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510(k) K961849

THE ROBOGUIDE by Shai Syg Motion and Innovations, Ltd. — Product Code IZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1996
Date Received
May 13, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mammographic
Device Class
Class II
Regulation Number
892.1710
Review Panel
RA
Submission Type

Other clearances by Shai Syg Motion and Innovations, Ltd.

  • K964460 — THE ROBOLITE (January 24, 1997)

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