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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 K020357
Device Name 800 SERIES EASYNEB NEBULIZER
Applicant
Nellcor Puritan Bennett, Inc.
4280 Hacienda Dr.
Pleasanton,  CA  94588 -2719
Applicant Contact GINA TO
Correspondent
Nellcor Puritan Bennett, Inc.
4280 Hacienda Dr.
Pleasanton,  CA  94588 -2719
Correspondent Contact GINA TO
Regulation Number868.5630
Classification Product Code
CAF  
Date Received02/04/2002
Decision Date 08/07/2002
Decision Substantially Equivalent (SESE)
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
Recalls CDRH Recalls
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