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KGB — Mask, Oxygen, Non-Rebreathing Class I

FDA Device Classification

Classification Details

Product Code
KGB
Device Class
Class I
Regulation Number
868.5570
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K970688cheen houng ent. co.POCKET RESCUESeptember 26, 1997
K960401hans rudolphULTIMATE SEALJune 20, 1996
K941336gam industriesCOMBO MASKSeptember 9, 1994
K935917bd becton dickinson vacutainer systems preanalyticCHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVESFebruary 4, 1994
K932347vital signsCOMPACT MASKJanuary 10, 1994
K933583hans rudolphNONREBREATHING VALVEJanuary 3, 1994
K933048laerdal medicalLAERDAL(TM) POCKET MASK, MODIFICATIONDecember 2, 1993
K930336fittydent-altwirth and schmittPROFAST(R)-DENTURE ADHESIVE CREAMAugust 24, 1993
K913164specialty packaging producsNON REBREATHING MASKJanuary 15, 1992
K883766medic oneMOUTH-TO-MASK VENTILATORY ADJUNCTOctober 21, 1988
K790162airlifeOXYGEN MASK, CONCENTRATION AEROSOL MASKApril 20, 1979
K790161airlifeOXYGEN MASK W/RESERVOIR BAGApril 20, 1979
K781414vitalab productsMASK, OXYGEN, NONBREATHINGSeptember 7, 1978