PMA P080020S005
- Device
- GEL-ONE
- Applicant
- Seikagaku Corp.
- PMA number
- P080020
- Supplement
- S005
- Product code
- MOZ
- Decision date
- 2013-08-23
- Classification
- Acid, Hyaluronic, Intraarticular
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- USE OF MANUFACTURING EQUIPMENT FOR DEVELOPMENT USE.
Current openFDA PMA Record#
- Device
- GEL-ONE
- Applicant
- Seikagaku Corp.
- PMA number
- P080020
- Supplement
- S005
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2013-08-23
- Decision code
- OK30
- Date received
- 2013-07-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- USE OF MANUFACTURING EQUIPMENT FOR DEVELOPMENT USE.