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510(k) K222549

Device
OpenTex
Applicant
Purgo Biologics, Inc.
510(k) number
K222549
Product code
NPK
Decision
Substantially Equivalent (SESE)
Decision date
2023-05-11
Date received
2022-08-23
Regulation
872.3930
Classification name
Barrier, Synthetic, Intraoral
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Byungsun Kim
Address
#812, 27 Dunchon-Daero 457 Beon-Gil, Jungwon-Gu Seongnam-Si KR 13219 13219

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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