Resure Sealant
FDA premarket approval P130004/S010 · decided 2020-12-17
Approval details
- PMA number
- P130004
- Supplement
- S010
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Resure Sealant
- Generic name
- Ophthalmic Sealant
- Applicant
- Ocular Therapeutix, Inc.
- Date received
- 2020-12-02
- Decision date
- 2020-12-17
- Days to decision
- 15 days
- Decision code
- OK30
- Product code
- PFZ
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Bedford, MA
- Statement
- to modify the test method for the ReSure Sealant Hydrogel and Dropper Bottle Performance
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| OCULAR FORCE GAUGE (K132917) | Ocular Therapeutix, Inc. | 2013-12-20 |