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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 K980074
Device Name 56 SERIES AEROSOL GENERATOR
Applicant
PROJECT MARKETING
112 CAVISTON WAY
CARY,  NC  27560
Applicant Contact TERRY O'BRIEN
Correspondent
PROJECT MARKETING
112 CAVISTON WAY
CARY,  NC  27560
Correspondent Contact TERRY O'BRIEN
Regulation Number868.5630
Classification Product Code
CAF  
Date Received01/08/1998
Decision Date 06/12/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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