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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K962872
Device Name RESPIFLO
Applicant
Tyco Healthcare Deutschaland GmbH
Raffineriestr. 18
Neustadt A D Donau,  DE D-93333
Applicant Contact WILLIAM D CURTIN
Correspondent
Tyco Healthcare Deutschaland GmbH
Raffineriestr. 18
Neustadt A D Donau,  DE D-93333
Correspondent Contact WILLIAM D CURTIN
Regulation Number868.5630
Classification Product Code
CAF  
Date Received07/23/1996
Decision Date 02/25/1997
Decision Substantially Equivalent - With Drug (SESD)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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