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510(k) K890566

BERMAN TYPE AIRWAY #59422-59429 VARIOUS SIZES by Medi-Source, Inc. — Product Code CAE

K890566 is an FDA 510(k) premarket notification submitted by Medi-Source, Inc. for the device "BERMAN TYPE AIRWAY #59422-59429 VARIOUS SIZES". The FDA issued a decision of Substantially Equivalent on March 15, 1989. The device falls under product code CAE (Airway, Oropharyngeal, Anesthesiology), a Class I device regulated under 21 CFR 868.5110. Medi-Source, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1989
Date Received
February 6, 1989
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 Medi-Source, Inc.

  • K903402 — GEOHESIVE (TM), MODEL NUMBERS 1022L, 1023L, 1026L (August 22, 1990)
  • K890565 — GELLHORN PESSARY 33410 VARIOUS SIZES (March 29, 1989)
  • K890567 — BITE BLOCK #59430 (February 17, 1989)

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