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510(k) K894032

EVAC-TUBE by Sharn, Inc. — Product Code CAO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 1989
Date Received
June 6, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Airway, Esophageal (Obturator)
Device Class
Class II
Regulation Number
868.5650
Review Panel
AN
Submission Type

Other clearances by Sharn, Inc.

  • K070596 — TOPICAL APPLICATOR (June 21, 2007)
  • K932305 — VILA-COOKE(TM) ANESTHESIA PILLOW (October 5, 1993)
  • K860558 — ESOPHAGEAL STETHOSCOPE (April 1, 1986)

Other clearances for product code CAO

  • K971348 — FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM (February 27, 1998)
  • K875226 — ESOPHAGEAL OBTURATOR/TRACHEAL TUBE (January 19, 1988)
  • K864200 — VETA/VENTED ESOPHAGEAL TUBE AIRWAY (March 17, 1987)
  • K863172 — RESPIRONICS PTL REVIVEEASY (November 4, 1986)
  • K761195 — ESOPHAGEAL OBTURATION AIRWAY (December 9, 1976)