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510(k) K935713

Device
WILEY/ESPOSITO DENTAL GUARD
Applicant
FVTNKS
510(k) number
K935713
Product code
BRW  
Decision
Substantially Equivalent (SESE)
Decision date
1994-01-05
Date received
1993-11-30
Regulation
868.5820
Classification name
Protector, Dental
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
PAUL E DRYDEN
Address
10415 Briggs Ct. Indianapolis IN US 46256 46256

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code BRW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K945727CATCO NEONATAL PALATE GUARDCatco Medical, Inc.1994-12-07
K851640TIP TOLEDO INCISOR PROTECTOREdward O. Goodwich1985-09-18

Legacy Summary#

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FDA Review#

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