FDA.reportPublic FDA data

510(k) K211420

Device
Stasis Gel
Applicant
Belport Company, Inc., Gingi-Pak
510(k) number
K211420
Product code
MVL
Decision
Substantially Equivalent (SESE)
Decision date
2022-03-14
Date received
2021-05-07
Classification name
Cord, Retraction
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Mohammed Islam
Address
4825 Calle Alto Camarillo CA US 93012 93012

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K162164GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction CordKerr Corporation2017-01-13
K152064Astringedent ClearUltradent Products, Inc.2015-09-24
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