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510(k) K883766

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

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

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  • 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)
  • K790162 — OXYGEN MASK, CONCENTRATION AEROSOL MASK (April 20, 1979)