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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 K926455
Device Name PARI FILTER/VALVE SET
Applicant
Paul Ritzau Pari-Werk GmbH
C/O Mcguire Woods Battle/Booth
901 E. Cary St.
Richmond,  VA  23219
Applicant Contact DEBORAH M RUSSELL
Correspondent
Paul Ritzau Pari-Werk GmbH
C/O Mcguire Woods Battle/Booth
901 E. Cary St.
Richmond,  VA  23219
Correspondent Contact DEBORAH M RUSSELL
Regulation Number868.5630
Classification Product Code
CAF  
Date Received12/24/1992
Decision Date 09/28/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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