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510(k) K874746

Device
SEALFLEX MASK
Applicant
ENGINEERED MEDICAL SYSTEMS
510(k) number
K874746
Product code
BSJ  
Decision
Substantially Equivalent (SESE)
Decision date
1987-12-21
Date received
1987-11-18
Regulation
868.5550
Classification name
Mask, Gas, Anesthetic
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JEFF QUINN
Address
P.O. Box 40543 Indianapolis IN US 46240 46240

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code BSJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K163277SuperNO2VA DeviceRevolutionary Medical Devices, Inc.2017-10-13
K953107ANESTHESIA/RESPIRATORY FACE MASKMedical Marketing Concepts1995-08-15
K953295ANESTHESIA FACE MASKMallinckrodt Medical1995-08-11
K952689BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASKOwens-Brigam Medical Co.1995-07-11
K951043AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASKPromedic, Inc.1995-06-07
K950771DISPOSABLE ADHESIVE FACE MASKAdvanced Warming Systems, Inc.1995-03-10
K945894MASK, GAS, ANESTHETICHans Rudolph, Inc.1995-01-27
K945440DISPOSABLE, ANESTHESIA/RESPIRATORY FACE MASKFvtnks1994-11-08
K944157DISPOSABLE, PREFORMED FACE MASKMeridian Medical Systems, Inc.1994-10-03
K932147NON CONDUCTIVE ANESTHESIA FACE MASK,SILICONEHans Rudolph, Inc.1993-08-20
K932014AMBU DISPOSABLE FACE MASKAmbu, Inc.1993-06-22
K915558IAS ANESTHESIA MASKIas1992-04-08
K903881VENTLAB VENT-MASK, CAT# VR 0010/20/30Ventlab Corp.1990-09-04
K902298ORAL-NASAL MASK RESUSCITATION AND ANESTHETIC GASRondex Products, Inc.1990-08-22
K891316ANESTHESIA/RESPIRATORY DISPOSABLE MASKConcord/Portex1989-08-21

Legacy Summary#

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FDA Review#

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