Gel-One
FDA premarket approval P080020/S035 · decided 2019-10-30
Approval details
- PMA number
- P080020
- Supplement
- S035
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Gel-One
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Seikagaku Corp.
- Date received
- 2019-08-01
- Decision date
- 2019-10-30
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Tokyo
- Statement
- Approval for a change to the design of the Finger Grip of the Gel-One container closure system.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| HADGEL, 4 GRAM/SYRINGE (K011544) | Seikagaku Corp. | 2001-08-15 |