FDA-STERILITY › Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile - Guidance for Industry and Food and Drug Administration Staff
Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile - Guidance for Industry and Food and Drug Administration Staff
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Document Number
1615
Revision Level
2016 EDITION
Status
Current
Publication Date
Jan. 21, 2016
Page Count
11 pages