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MASAMUNE Ken
Department Research Institutes and Facilities, Research Institutes and Facilities Position Professor |
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| Article types | Original article |
| Language | English |
| Peer review | Peer reviewed |
| Title | Assessment of Regulatory Compliance Issues Involving Reprocessing of Single-Use Devices in the United States |
| Journal | Formal name：Pharmaceutical and medical device regulatory science ISSN code：18846076 |
| Domestic / Foregin | Domestic |
| Volume, Issue, Page | 46(11),pp.788-796 |
| Author and coauthor | MATSUMOTO Toru†, MATSUMOTO Keisuke, NAKAZAKI Tomomichi, ISEKI Hiroshi, MASAMUNE Ken |
| Publication date | 2015/11 |
| Summary | PDF Not find!
Single-Use Device (SUD) Reprocessing 510 (k) Quality System Regulation (QSR) Recall Design change U.S. Food and Drug Administration (FDA) |
| NAID | 40020653408 |