PMA P010018S001
- Device
- VIEWPOINT CK SYSTEM (KERATOPLAST TIP COMPONENT)
- Applicant
- Refractec, Inc.
- PMA number
- P010018
- Supplement
- S001
- Product code
- MWD
- Decision date
- 2002-10-28
- Classification
- Ophthalmic
- Generic name
- Electrosurgical, radio frequency, refractive correction
- Approval order statement
- ALTERNATIVE/ EQUIVALENT UV CURABLE ADHESIVE TO BE USED IN THE BONDING PROCESS DURING MANUFACTURE OF THE KERATOPLAST TIP.
Current openFDA PMA Record#
- Device
- VIEWPOINT CK SYSTEM (KERATOPLAST TIP COMPONENT)
- Applicant
- Refractec, Inc.
- PMA number
- P010018
- Supplement
- S001
- Product code
- MWD
- Generic name
- Electrosurgical, radio frequency, refractive correction
- Decision date
- 2002-10-28
- Decision code
- OK30
- Date received
- 2002-10-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ALTERNATIVE/ EQUIVALENT UV CURABLE ADHESIVE TO BE USED IN THE BONDING PROCESS DURING MANUFACTURE OF THE KERATOPLAST TIP.