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U.S. Department of Health and Human Services

Product Classification
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Device media, culture, ex vivo, tissue and cell
Regulation Description Tissue culture media for human ex vivo tissue and cell culture processing applications.
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeNDS
Premarket Review Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
Submission Type 510(k)
Regulation Number 876.5885
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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