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510(k) K821993

SHILEY LARYNGECTOMY TUBE by Shiley, Inc. — Product Code KAC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1982
Date Received
July 7, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Laryngectomy
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
Submission Type

Other clearances by Shiley, Inc.

  • K920594 — SHILEY PERFUSION TUBING SETS (March 18, 1993)
  • K910991 — SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM (November 27, 1991)
  • K911876 — SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200 (August 9, 1991)
  • K910923 — BCD ADVANCED (April 9, 1991)
  • K901548 — BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS (January 14, 1991)
  • K903435 — SHILEY SPECIALIZED TRACHEOSTOMY TUBE (October 2, 1990)
  • K901624 — SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY. (July 3, 1990)
  • K901250 — PLEXUS 2(TM) INFANT HOLLOW FIBER OXYGENATOR (June 11, 1990)
  • K901249 — PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR (June 11, 1990)
  • K900797 — STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR (May 10, 1990)

Other clearances for product code KAC

  • K901377 — BARTON-MAYO TRACHEOSTOMA BUTTON (June 14, 1990)
  • K873992 — LARYNGECTOMY TUBE (March 24, 1988)
  • K811428 — NORTHWESTERN VOICE RESTORATION KIT (June 16, 1981)