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510(k) K012373

LIFERAY WL CASSETTE, LIFERAY KW CASSETTE by Ferrania S.P.A. — Product Code IXA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 2001
Date Received
July 26, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Cassette, Radiographic Film
Device Class
Class II
Regulation Number
892.1850
Review Panel
RA
Submission Type

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  • K983918 — RADIOLUCENT CASSETTE LIMB POSITIONER (R-CLIP) (March 12, 1999)
  • K980722 — TRIMAX RADIOGRAPHIC CASSETTE (March 23, 1998)
  • K963914 — CM & CM DS-7 (October 8, 1997)