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510(k) K860780

Device
PLASTIC MOUTH BARRIER HCV-E
Applicant
WESTMARK ENTERPRISES, INC.
510(k) number
K860780
Product code
CAE  
Decision
Substantially Equivalent (SESE)
Decision date
1986-04-02
Date received
1986-03-03
Regulation
868.5110
Classification name
Airway, Oropharyngeal, Anesthesiology
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
MARK D WESTFALL
Address
8710 Trumbull Ave. Skokie IL US 60076 60076

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CAE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K130304LMA FAMILY OF AIRWAYSThe Laryngeal Mask Co., Ltd.2014-05-30
K033189KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305King Systems Corp.2004-05-04
K033186KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205King Systems Corp.2004-04-14
K021634KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105King Systems Corp.2003-01-09
K955721CUFFED OROPHARYNGEAL AIRWAY (COPA)Mallinckrodt Medical1997-03-28
K960240RUSCH OPTOSAFERusch Intl.1996-04-19
K950613KEISEIKeisei (Usa) Co., Ltd.1996-02-14
K953400GUEDEL AIRWAYMallinckrodt Medical1995-10-24
K933760STB GUEDEL AIRWAYSave-T-Breath Distributors C.C.1994-03-23
K936134BERMAN AIRWAYSmiths Industries Medical Systems, Inc.1994-01-28
K922748GUEDEL AIRWAYOem Medical Div.1992-07-10
K913680BERMAN INTUBATING/PHARYNGEAL AIRWAYChain Plastics Operations, Inc.1991-10-10
K904834INTAVENT LARYNGEAL MASKIntavent Intl. S.A.1991-07-26
K891926KISS OF LIFEAnthony Don Michael, M.D.1989-08-21
K892123GOETTINGER EMERGENCY RESUSCITATION TUBEPlastic Parts Corp.1989-07-14

Legacy Summary#

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FDA Review#

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