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RODIN 3D Resin SPLINT, Hard/Flex

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231793
510(k) Type
Traditional
Applicant
Belport Company, Inc., Gingi-Pak
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/26/2024
Days to Decision
280 days
Submission Type
Statement

RODIN 3D Resin SPLINT, Hard/Flex

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231793
510(k) Type
Traditional
Applicant
Belport Company, Inc., Gingi-Pak
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/26/2024
Days to Decision
280 days
Submission Type
Statement