PMA P050027S005

Device: KARL STORZ PHOTODYNAMIC D-LIGHT C (PDD) SYSTEM
Applicant: KARL STORZ Endoscopy-America, Inc.
PMA number: P050027
Supplement: S005
Product code: OAY
Decision date: 2013-09-23
Classification: Light Source System, Diagnostic Endoscopic
Generic name: Light source system, diagnostic endoscopic
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT KARL STORZ GMBH & CO., IN TUTTLINGEN, GERMANY TO MANUFACTURE THE C LIGHT SOURCE.

Current openFDA PMA Record#

Device: KARL STORZ PHOTODYNAMIC D-LIGHT C (PDD) SYSTEM
Applicant: KARL STORZ Endoscopy-America, Inc.
PMA number: P050027
Supplement: S005
Product code: OAY
Generic name: Light source system, diagnostic endoscopic
Decision date: 2013-09-23
Decision code: APPR
Date received: 2013-03-18
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT KARL STORZ GMBH & CO., IN TUTTLINGEN, GERMANY TO MANUFACTURE THE C LIGHT SOURCE.