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medical device regulation

This is the product
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170012
P170012B is supplement material, also can be found on this website.

Device    HEMOBLAST Bellows
Generic Name    Absorbable Collagen Hemostatic Agent With Thrombin
Regulation Number    878.4490

 

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