PMA P010018S004

Device: VIEWPOINT CK SYSTEM
Applicant: Refractec, Inc.
PMA number: P010018
Supplement: S004
Product code: MWD
Decision date: 2003-07-31
Classification: Ophthalmic
Generic name: Electrosurgical, radio frequency, refractive correction
Approval order statement: APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY FOR THE SUB-ASSEMBLY OF THE RCS-300 CONSOLE. THE MANUFACTURING FACILITY IS LOCATED AT REFRACTEC, INC., IRVINE, CALIFORNIA.

Current openFDA PMA Record#

Device: VIEWPOINT CK SYSTEM
Applicant: Refractec, Inc.
PMA number: P010018
Supplement: S004
Product code: MWD
Generic name: Electrosurgical, radio frequency, refractive correction
Decision date: 2003-07-31
Decision code: APPR
Date received: 2003-07-16
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Express GMP Supplement
Approval order statement: APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY FOR THE SUB-ASSEMBLY OF THE RCS-300 CONSOLE. THE MANUFACTURING FACILITY IS LOCATED AT REFRACTEC, INC., IRVINE, CALIFORNIA.