510(k) DEN180060
- Device
- Plenity
- Applicant
- Gelesis, Inc.
- 510(k) number
- DEN180060
- Product code
- QFQ
- Decision
- Unknown (DENG)
- Decision date
- 2019-04-12
- Date received
- 2018-11-15
- Regulation
- 876.5982
- Classification name
- Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Eyal Ron
- Address
- 501 Boylston St., Suite 6102 Boston MA US 02116 02116
FDA Registration Numbers#
- 3039243252
- 3016096098
- 3021033331
- 3012121187
- 3033524253
Source Documents#
510(k) summary PDF not indicated by FDA