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510(k) K883312

L-F/KODAK FLEXIBLE GRID CASSETTE by Mallinckrodt Group, Inc. — Product Code IXA

K883312 is an FDA 510(k) premarket notification submitted by Mallinckrodt Group, Inc. for the device "L-F/KODAK FLEXIBLE GRID CASSETTE". The FDA issued a decision of Substantially Equivalent on August 16, 1988. The device falls under product code IXA (Cassette, Radiographic Film), a Class II device regulated under 21 CFR 892.1850. Mallinckrodt Group, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 1988
Date Received
August 5, 1988
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

Other clearances by Mallinckrodt Group, Inc.

  • K945053 — LF CT HIG PRESSURE CATHETERS (May 19, 1995)
  • K945140 — URO-FLO (March 8, 1995)
  • K943581 — HYDRADJUST IV UROLOGICAL TABLE (January 4, 1995)
  • K943122 — SURGICAL DRAPES (September 7, 1994)
  • K934664 — HYDRAGOWN (May 24, 1994)
  • K920742 — HYDRAJUST IV UROLOGICAL TABLE (April 27, 1992)
  • K912944 — CT 8000 DIGITAL INJECTION SYSTEM (February 4, 1992)
  • K913264 — HYDRAVIEW 1000 DIGITAL IMAGE PROCESS/STOR DEVICE (November 1, 1991)
  • K905789 — FRANKLIN 9000 WALL STAND (May 20, 1991)
  • K904145 — HYDRA VISION UROLOGICAL X-RAY SYSTEM (December 13, 1990)

Other clearances for product code IXA

  • K081557 — PORTABLE SUPINE PATIENT SUPPORT AND CASSETTE HOLDER (September 10, 2008)
  • K053173 — DS CASSETTE (December 15, 2005)
  • K040378 — KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253 (May 24, 2004)
  • K023020 — AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX (September 26, 2002)
  • K021903 — KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE (July 10, 2002)
  • K013686 — KODAK DIRECTVIEW TABLETOP CASSETTE (December 7, 2001)
  • K013229 — LIFERAY FW MAMMO CASSETTE, LIFERAY KW MAMMO CASETTE (October 12, 2001)
  • 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)

FDA data resources