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510(k) K896691

Device
BITE BLOCK
Applicant
ENDOSCOPIX
510(k) number
K896691
Product code
MNK  
Decision
Substantially Equivalent (SESE)
Decision date
1990-02-12
Date received
1989-11-28
Regulation
876.1500
Classification name
Endoscopic Bite Block
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
MICHAEL BRADBURY
Address
18907 Nordhoff 38b Northridge CA US 91324 91324

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
K944049OXYGEN MOUTHGUARDEndovations, Inc.1994-10-11
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

Legacy Summary#

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FDA Review#

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