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TOP CALIBRE SDN. BHD. K 23 i FDA 510(k), Premarket Notification: 510(k) Summary of Safety and Effectiveness Information
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Document Date: 2013-04-11 12:53:16

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File Size: 284,85 KB

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Company

TOP CALIBRE SDN. / Rosnita Maodin Quality Assurance Manager Top Calibre Sdn Bhd / K123819 Trade / Shah Malaysia Sdn Bhd / /

Event

FDA Phase / /

Facility

General Hospital / /

IndustryTerm

predicate device / manufacturing / marketed device / /

MedicalTreatment

Chemotherapy / /

Organization

Food and Drug Administration / office of Device Evaluation / FDA / DEPARTMENT OF HEALTH / /

Person

Silver Spring / Elizabeth fia / Cosmetic Act (Act) / Anthony D. Watson / /

/

Position

Director / Major / /

Product

Cisplatin / Etoposide / Paclitaxel / Cytoxan / Cytarabine / Cyclophosphamide / Doxorubicin Hydrochloride / Ifosfamide / Vincristine Sulfate / Fluorouracil / Taxol / Thiotepa / Mitoxantrone / Mitomycin / Dacarbazine / device / /

ProgrammingLanguage

Latex / /

ProvinceOrState

Maryland / /

Technology

radiation / Chemotherapy / /

URL

www.fda.gov/AboutFDA/CentersOffices/CDRHICDRHOffices/ucm / http /

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