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510(k) K945727

Device
CATCO NEONATAL PALATE GUARD
Applicant
CATCO MEDICAL, INC.
510(k) number
K945727
Product code
BRW  
Decision
Substantially Equivalent (SESE)
Decision date
1994-12-07
Date received
1994-11-22
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
CLYDE N BAKER
Address
9010 Foxland Dr. San Antonio TX US 78230 78230

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
K935713WILEY/ESPOSITO DENTAL GUARDFvtnks1994-01-05
K851640TIP TOLEDO INCISOR PROTECTOREdward O. Goodwich1985-09-18

Legacy Summary#

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FDA Review#

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