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510(k) K863375

Device
SEA-BOND
Applicant
COMBE, INC.
510(k) number
K863375
Product code
KXX  
Decision
Substantially Equivalent (SESE)
Decision date
1986-09-19
Date received
1986-09-03
Regulation
872.3450
Classification name
Adhesive, Denture, Karaya And Ethylene-oxide Homopolymer
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DANIEL R JOHNSON
Address
1101 Westchester Ave. White Plains NY US 10604 10604

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Legacy Summary#

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FDA Review#

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