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510(k) K934478

ALPHA STEREO by Instrumentarium Corp. — Product Code IZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 1995
Date Received
September 14, 1993
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

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