PMA P010018S006

Device: VIEWPOINT CK SYSTEM
Applicant: Refractec, Inc.
PMA number: P010018
Supplement: S006
Product code: MWD
Decision date: 2004-01-15
Classification: Ophthalmic
Generic name: Electrosurgical, radio frequency, refractive correction
Approval order statement: APPROVAL FOR AN ALTERNATE MANUFACTURING SITE FOR THE SUB-ASSEMBLY OF THE RCS-300 CONSOLE COMPONENT AT STELLARTECH RESEARCH CORP., SUNNYVALE, CALIFORNIA.

Current openFDA PMA Record#

Device: VIEWPOINT CK SYSTEM
Applicant: Refractec, Inc.
PMA number: P010018
Supplement: S006
Product code: MWD
Generic name: Electrosurgical, radio frequency, refractive correction
Decision date: 2004-01-15
Decision code: APPR
Date received: 2003-12-04
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR AN ALTERNATE MANUFACTURING SITE FOR THE SUB-ASSEMBLY OF THE RCS-300 CONSOLE COMPONENT AT STELLARTECH RESEARCH CORP., SUNNYVALE, CALIFORNIA.