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In an Abbreviated 510(k), FDA may consider the contents of a summary report to be appropriate supporting data within the meaning of 21 CFR 807.87(f) or (g); therefore, we recommend that you ...

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Guidance for Industry and FDA Staff . Surgical Masks - Premarket Notification [510(k)] Submissions . Document issued on: March 5, 2004 and a correction posted on July 14, 2004.

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Arkansas Department of Health

Jan 01, 2010 · ii) Certification or re-certification by a national certifying body recognized by the ASBN; or iii) An academic course in nursing or related field; and iv) Active practice of nursing for a minimum of one thousand hours (1,000) within the one year immediately prior to application.

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a. oral iron preparation The Centers for Disease Control and Prevention (CDC) has defined anemia as hemoglobin levels of less than 11 g/dL (hematocrit less than 33 percent) in the first and third trimesters and less than 10.5 g/dL (hematocrit less than 32 percent) in the second trimester [21].

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For biological products regulated under 21 CFR parts 600 through 680, §§ 210.2(a) and 211.1(b) provide that where it is impossible to comply with the applicable regulations in both parts 600 through 680 and parts 210 and 211, the regulation specifically applicable to the drug product in question shall supercede the more general regulations.

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