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Device | KARL STORZ PHOTODYNAMIC D-LIGHT C (PDD) SYSTEM |
Generic Name | Light source system, diagnostic endoscopic |
Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVE. EL SEGUNDO, CA 90245 |
PMA Number | P050027 |
Supplement Number | S005 |
Date Received | 03/18/2013 |
Decision Date | 09/23/2013 |
Product Code |
OAY |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT KARL STORZ GMBH & CO., IN TUTTLINGEN, GERMANY TO MANUFACTURE THE C LIGHT SOURCE. |