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510(k) K914530

ICAN GT DRAINAGE BAG by Icn Pharmaceuticals, Inc. — Product Code FRQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1991
Date Received
October 11, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Levine
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Other clearances by Icn Pharmaceuticals, Inc.

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  • K951329 — IMMUCHEM GAL-MW EA (November 9, 1995)
  • K914082 — SUAN FLAT DISSECTOR SPONGES (November 27, 1991)
  • K914086 — ICAN CYLINDRICAL SPONGES (October 9, 1991)
  • K914081 — ICAN COTTON RAYON BALLS (October 9, 1991)
  • K914083 — ICAN K DISSECTOR SPONGES (October 9, 1991)
  • K913446 — ICAN NEEDLE COUNTERS (September 13, 1991)
  • K904398 — WATER COLUMN RELIEF VALVE (July 9, 1991)
  • K770458 — BILIRUBIN PROCEDURE, TEKPOINT TOT & DIR. (May 10, 1977)
  • K770449 — CALCIUM PROCEDURE, TEKPOINT DIRECT (May 3, 1977)

Other clearances for product code FRQ

  • K914887 — ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR/GASTRIC SUCT (May 8, 1992)
  • K802007 — PEDIWET=GUAZE IMPREGNATED WITH PETROL (September 26, 1980)