PMA P990078
- Device
- HYPERION LTK SYSTEM
- Applicant
- Sunrise Technologies, Inc.
- PMA number
- P990078
- Supplement
- S005
- Product code
- HQF
- Decision date
- 2002-05-08
- Classification
- Laser, Ophthalmic
- Generic name
- Laser, ophthalmic
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT A-PLUS/C-MAC, FREMONT, CALIFORNIA.
Current openFDA PMA Record#
- Device
- HYPERION LTK SYSTEM
- Applicant
- Sunrise Technologies, Inc.
- PMA number
- P990078
- Supplement
- S005
- Product code
- HQF
- Generic name
- Laser, ophthalmic
- Decision date
- 2002-05-08
- Decision code
- APPR
- Date received
- 2001-08-20
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT A-PLUS/C-MAC, FREMONT, CALIFORNIA.