PMA P010018S008
- Device
- VIEWPOINT CK SYSTEM
- Applicant
- Refractec, Inc.
- PMA number
- P010018
- Supplement
- S008
- Product code
- MWD
- Decision date
- 2005-09-30
- Classification
- Ophthalmic
- Generic name
- Electrosurgical, radio frequency, refractive correction
- Approval order statement
- IMPLEMENTATION OF A CONTROLLED ADHESIVE APPLICATION PROCESS TO MORE ACCURATELY CONTROL THE AMOUNT OF ADHESIVE APPLIED.
Current openFDA PMA Record#
- Device
- VIEWPOINT CK SYSTEM
- Applicant
- Refractec, Inc.
- PMA number
- P010018
- Supplement
- S008
- Product code
- MWD
- Generic name
- Electrosurgical, radio frequency, refractive correction
- Decision date
- 2005-09-30
- Decision code
- OK30
- Date received
- 2005-09-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- IMPLEMENTATION OF A CONTROLLED ADHESIVE APPLICATION PROCESS TO MORE ACCURATELY CONTROL THE AMOUNT OF ADHESIVE APPLIED.