Name: Predicase
Price: 199 USD

K-number	K171162
Device name	Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield
Applicant	Prestige Ameritech
Product code	FXX
Device class	Class II
Decision date	Aug 15, 2017
Decision	Substantially Equivalent
Regulation	878.4040

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield

Everything you need for a 510(k) submission. Nothing you don't.