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Plenity

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
DEN180060
510(k) Type
Direct
Applicant
Gelesis, Inc.
Country
United States
FDA Decision
Deleted
Decision Date
4/12/2019
Days to Decision
148 days

Plenity

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
DEN180060
510(k) Type
Direct
Applicant
Gelesis, Inc.
Country
United States
FDA Decision
Deleted
Decision Date
4/12/2019
Days to Decision
148 days