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510(k) K070596

TOPICAL APPLICATOR by Sharn, Inc. — Product Code CCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2007
Date Received
March 2, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Applicator (Laryngo-Tracheal), Topical Anesthesia
Device Class
Class II
Regulation Number
868.5170
Review Panel
AN
Submission Type

Other clearances by Sharn, Inc.

  • K932305 — VILA-COOKE(TM) ANESTHESIA PILLOW (October 5, 1993)
  • K894032 — EVAC-TUBE (August 31, 1989)
  • K860558 — ESOPHAGEAL STETHOSCOPE (April 1, 1986)

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  • K002255 — LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC) (September 18, 2000)
  • K894755 — ASTRA DISPOSABLE SPRAY CANNULA (January 12, 1990)
  • K810059 — ENDO-MED TUBE FOR ENDOTRACHEAL MED (February 26, 1981)
  • K760759 — ANESTHESIA KIT (December 9, 1976)
  • K760877 — MONOJECT LARYNGOTRACHEAL ANESTHESIA KIT (December 9, 1976)