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510(k) K152322

Device
Resolve 2.0
Applicant
DENALI CORPORATION
510(k) number
K152322
Product code
PME  
Decision
Substantially Equivalent (SESE)
Decision date
2015-12-16
Date received
2015-08-17
Regulation
872.3260
Classification name
External Cleaning Solution
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jan G Stannard
Address
134 Old Washington St. Hanover MA US 02339 02339

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PME  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K191133KATANA Cleaner, KATANA Cleaner (Trial)Kuraray Noritake Dental, Inc.2019-10-08
K163171CeraCleanBisco, Inc.2017-04-14

Legacy Summary#

summary

FDA Review#

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