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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 K961894
Device Name MDI TUTOR
Applicant
MDI TUTOR, INC.
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Applicant Contact DIANE E MINEAR
Correspondent
MDI TUTOR, INC.
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Correspondent Contact DIANE E MINEAR
Regulation Number868.5640
Classification Product Code
CCQ  
Date Received05/16/1996
Decision Date 08/14/1996
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
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