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LLC 9735 Green Park Industrial Drive St. Louis Missouri 63123 but not limited to We have reviewed your firm's response of July 9 In your response

In your response Your response however

(b)(4) ) listed for each filter. In addition In your response b. In addition In addition For example including sampling frequency sampling locations In your response

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According to their labeling the above listed products are intended to cure mitigate treat or prevent diseases (b)(4) Ear Drop: Ringing Buzzing (b)(4) Pink Eye: Intended for inflamed

Based on the above labeling and claims 321(g)(1)(B)

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or prevention of disease in man and under section 201(g)(1)(C) of the Act 321(g)(1)(C) Section 503(b)(1) of the Act 21 U.S.C. 353(b)(1) 250 Marquette Avenue Suite 600 Minneapolis

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