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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 K896070
Device Name PFEIFFER METERED DOSAGE SYSTEM
Applicant
SYVA CO.
900 ARASTRADERO RD.
P.O. BOX 10058
PALO ALTO,  CA  94303
Applicant Contact ROGERS, JR
Correspondent
SYVA CO.
900 ARASTRADERO RD.
P.O. BOX 10058
PALO ALTO,  CA  94303
Correspondent Contact ROGERS, JR
Regulation Number868.5640
Classification Product Code
CCQ  
Date Received10/19/1989
Decision Date 01/17/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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