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510(k) K904719

Device
DISPOSABLE FACE MASK
Applicant
TRI/BOR MEDICAL, INC.
510(k) number
K904719
Product code
BYG  
Decision
Substantially Equivalent (SESE)
Decision date
1991-01-02
Date received
1990-10-18
Regulation
868.5580
Classification name
Mask, Oxygen
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
KATHLEEN MIRESSI
Address
P.O. Box 419 Westtown NY US 10998 10998

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code BYG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K963298FIRST AID KIT(S)Vector, Inc.1996-11-06
K962848HANS RUDOLPH NASAL CPAP MASKHans Rudolph, Inc.1996-10-16
K945482DISPOSABLE, CPAP OXYGEN MASKFvtnks1995-09-19
K953464WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASKWestmed, Inc.1995-09-18
K953039VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKSDadsun Corp., Ltd.1995-09-15
K945472WESTMED PEDIATRIC AND ADULT AEROSOL MASKWestmed Intl.1995-02-07
K942907JEMSDAL MASKRespan Products, Inc.1994-08-31
K940887SYSTEM 22 ADULT MASKMedic-Aid , Ltd.1994-04-19
K940888SYSTEM 22 PAEDIATRIC MASKMedic-Aid , Ltd.1994-04-19
K931952MEDWAY OXYGEN MASKMedway1993-08-20
K924069SURGICO OXYGEN MASKGujarat Surgico, Ltd.1993-02-04
K921499SEAL RING FOR NASAL CPAPDevilbiss Health Care, Inc.1992-09-17
K913501TRACHEOSTOMY MASKB & F Medical Products, Inc.1992-01-13
K913383OXYGEN MASKS 81420, 81421, 81471 & 81461Specialty Packaging Producs, Inc.1991-10-18
K913275VENTURI OXYGEN MASKSpecialty Packaging Producs, Inc.1991-10-10

Legacy Summary#

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FDA Review#

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