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510(k) K020995

EFILM WORKSTATION WITH MODULES by Efilm Medical, Inc. — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2002
Date Received
March 28, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

Other clearances by Efilm Medical, Inc.

  • K013631 — EFILM VIDEO (November 20, 2001)
  • K012211 — EFILM WORKSTATION (July 31, 2001)

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