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510(k) K944049

Device
OXYGEN MOUTHGUARD
Applicant
ENDOVATIONS, INC.
510(k) number
K944049
Product code
MNK  
Decision
Substantially Equivalent (SESE)
Decision date
1994-10-11
Date received
1994-08-18
Regulation
876.1500
Classification name
Endoscopic Bite Block
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
RONALD D WOLFE
Address
P.O. Box 6386 Hill And George Aveenues Reading PA US 19610 19610

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MNK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K933537ENCOMPAS COMFORT BLOCK # 0B-10Encompas Unlimited, Inc.1994-04-08
K931044OXY-BLOCGi Supply1993-10-04
K924764OVERTUBE FOR ENDSCOPIC LIGATORSuperior Healthcare Group, Inc.1993-03-15
K914978OXYGUARDStantex Pty , Ltd.1992-01-10
K896691BITE BLOCKEndoscopix1990-02-12

Legacy Summary#

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FDA Review#

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