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510(k) K883766

MOUTH-TO-MASK VENTILATORY ADJUNCT by Medic One — Product Code KGB

K883766 is an FDA 510(k) premarket notification submitted by Medic One for the device "MOUTH-TO-MASK VENTILATORY ADJUNCT". The FDA issued a decision of Substantially Equivalent on October 21, 1988. The device falls under product code KGB (Mask, Oxygen, Non-Rebreathing), a Class I device regulated under 21 CFR 868.5570.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 1988
Date Received
September 6, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mask, Oxygen, Non-Rebreathing
Device Class
Class I
Regulation Number
868.5570
Review Panel
AN
Submission Type

Other clearances for product code KGB

  • K970688 — POCKET RESCUE (September 26, 1997)
  • K960401 — ULTIMATE SEAL (June 20, 1996)
  • K941336 — COMBO MASK (September 9, 1994)
  • K935917 — CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVES (February 4, 1994)
  • K932347 — COMPACT MASK (January 10, 1994)
  • K933583 — NONREBREATHING VALVE (January 3, 1994)
  • K933048 — LAERDAL(TM) POCKET MASK, MODIFICATION (December 2, 1993)
  • K930336 — PROFAST(R)-DENTURE ADHESIVE CREAM (August 24, 1993)
  • K913164 — NON REBREATHING MASK (January 15, 1992)
  • K790161 — OXYGEN MASK W/RESERVOIR BAG (April 20, 1979)

FDA data resources