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510(k) K810069

STERILE AIRWAY by Medspec Corp. — Product Code CAE

K810069 is an FDA 510(k) premarket notification submitted by Medspec Corp. for the device "STERILE AIRWAY". The FDA issued a decision of Substantially Equivalent on February 2, 1981. The device falls under product code CAE (Airway, Oropharyngeal, Anesthesiology), a Class I device regulated under 21 CFR 868.5110. Medspec Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1981
Date Received
January 13, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Airway, Oropharyngeal, Anesthesiology
Device Class
Class I
Regulation Number
868.5110
Review Panel
AN
Submission Type

Other clearances by Medspec Corp.

  • K813012 — STERILE BASIN SETS (November 6, 1981)
  • K812707 — STERILE DISSECTOR SPONGES-X-RAY DETECT (November 2, 1981)
  • K812710 — STERILE LAPAROTOMY SPONGES-X-RAY DETECT (November 2, 1981)
  • K812711 — STERILE GAUZE PADS 12PLY (November 2, 1981)
  • K812709 — STERILE DENTAL ROLL (October 23, 1981)
  • K810071 — STERILE SILICONE TUBING (February 12, 1981)
  • K802060 — STERILE TONSIL SPONGES (October 10, 1980)
  • K801069 — STERILE ISOLATION GOWN (May 20, 1980)
  • K801068 — STERILE ABDOMINAL PAD (May 20, 1980)
  • K800278 — MEDSPEC SAFETY PINS (May 2, 1980)

Other clearances for product code CAE

  • K130304 — LMA FAMILY OF AIRWAYS (May 30, 2014)
  • K033189 — KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 30 (May 4, 2004)
  • K033186 — KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205 (April 14, 2004)
  • K021634 — KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105 (January 9, 2003)
  • K955721 — CUFFED OROPHARYNGEAL AIRWAY (COPA) (March 28, 1997)
  • K960240 — RUSCH OPTOSAFE (April 19, 1996)
  • K950613 — KEISEI (February 14, 1996)
  • K953400 — GUEDEL AIRWAY (October 24, 1995)
  • K933760 — STB GUEDEL AIRWAY (March 23, 1994)
  • K936134 — BERMAN AIRWAY (January 28, 1994)

FDA data resources