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510(k) K911041

INVOTEC X-RAY CASSETTE EQUIPMENT DRAPE by Invotec International, Inc. — Product Code IXA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 1991
Date Received
March 8, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K013686 — KODAK DIRECTVIEW TABLETOP CASSETTE (December 7, 2001)
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  • K012373 — LIFERAY WL CASSETTE, LIFERAY KW CASSETTE (August 9, 2001)
  • K983918 — RADIOLUCENT CASSETTE LIMB POSITIONER (R-CLIP) (March 12, 1999)
  • K980722 — TRIMAX RADIOGRAPHIC CASSETTE (March 23, 1998)