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In addition FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. Pauline Maralit Regulatory Affairs Specialist One Medline Place Mundelein IL 60060 Re K160471 Trade/Device Name Medline Isolation...
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