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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
510(k) Number K851525
Device Name PFEIFFER PUMP
Applicant
Ing. Erich Pfeiffer GmbH & Co. Kg.
Postfach 1460
D-7760
Radolfzell,  DE
Applicant Contact PETER PFEIFFER
Correspondent
Ing. Erich Pfeiffer GmbH & Co. Kg.
Postfach 1460
D-7760
Radolfzell,  DE
Correspondent Contact PETER PFEIFFER
Regulation Number868.5640
Classification Product Code
CCQ  
Date Received04/16/1985
Decision Date 08/08/1985
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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