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510(k) K914081

ICAN COTTON RAYON BALLS by Icn Pharmaceuticals, Inc. — Product Code FRL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 1991
Date Received
September 11, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fiber, Medical, Absorbent
Device Class
Class I
Regulation Number
880.5300
Review Panel
HO
Submission Type

Other clearances by Icn Pharmaceuticals, Inc.

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  • K951329 — IMMUCHEM GAL-MW EA (November 9, 1995)
  • K914530 — ICAN GT DRAINAGE BAG (December 18, 1991)
  • K914082 — SUAN FLAT DISSECTOR SPONGES (November 27, 1991)
  • K914083 — ICAN K DISSECTOR SPONGES (October 9, 1991)
  • K914086 — ICAN CYLINDRICAL 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)

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  • K931626 — CARAPACE STERILE COTTON BALLS (December 2, 1993)
  • K811990 — TRACH CLEANING TRAY (July 27, 1981)
  • K810242 — UTENSIL & PROCEDURE TRAYS (April 15, 1981)
  • K800277 — MEDSPEC RAYON BALLS (March 12, 1980)
  • K800248 — SURGITEK FOERSTER FACE LIFT BANDAGE (February 19, 1980)
  • K800249 — SURGITEK FOERSTER MAMMARY BANDAGE (February 19, 1980)
  • K792295 — SORBIES (December 20, 1979)