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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 K935955
Device Name DOSER
Applicant
NEWMED CORP.
740 MAIN STREET, SUITE 107
WALTHAM,  MA  02154
Applicant Contact DEBBIE IAMPIETRO
Correspondent
NEWMED CORP.
740 MAIN STREET, SUITE 107
WALTHAM,  MA  02154
Correspondent Contact DEBBIE IAMPIETRO
Regulation Number868.5630
Classification Product Code
CAF  
Date Received12/13/1993
Decision Date 09/16/1994
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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