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ISO SYSTEM
- ISO13485 In Vitro Diagnostic/ Medical Devices
- ISO 22716 Cosmetics
- ISO 27001 Information Security
- ISO 27701 Privacy Information Management
- ISO 45001 Occupational Health and Safety
- ISO 15378 Primary Packaging Materials
- ISO 22000 Food Safety
- ISO 9001 Quality Management
- ISO 14001 Environmental Management
- ISO 10002 Customer Satisfaction
- ISO 22301 Business Continuity
- ISO 37001 Anti-bribery Management
- TRAINING CENTER
- ACHIEVEMENT
- ICMC NEWS & LIBRARY
- NOTICE
- CUSTOMER
- ABOUT ICMC
- DOMESTIC RA
- GLOBAL RA
-
ISO SYSTEM
- ISO13485 In Vitro Diagnostic/ Medical Devices
- ISO 22716 Cosmetics
- ISO 27001 Information Security
- ISO 27701 Privacy Information Management
- ISO 45001 Occupational Health and Safety
- ISO 15378 Primary Packaging Materials
- ISO 22000 Food Safety
- ISO 9001 Quality Management
- ISO 14001 Environmental Management
- ISO 10002 Customer Satisfaction
- ISO 22301 Business Continuity
- ISO 37001 Anti-bribery Management
- TRAINING CENTER
- ACHIEVEMENT
- ICMC NEWS & LIBRARY
- NOTICE
ICMC NEWS & LIBRARY
ICMC (International Certification Management Center Co., Ltd.)
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Medical Devices FDA
icmcert@naver.com
+82-2-851-3111
Medical Devices FDA
[FDA] 510(k) Submission Methods
- Admin Hits:524
- 2018-04-06 19:35:00
FDA의 Medical Devices에서는 Site내에 민원인들의 편의성을 위하여 "510(k) Submission Methods"를 제시하고 있습니다.
아래 링크를 통하여 "510(k) Submission Methods"를 확인해 보시기 바랍니다.
관련 링크 : https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm134034.htm
아래 링크를 통하여 "510(k) Submission Methods"를 확인해 보시기 바랍니다.
관련 링크 : https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm134034.htm
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