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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 K854520
Device Name PULMO-AIDE MODEL 5610D
Applicant
The Devilbiss Co.
P.O. Box 635
Somerset,  PA  15501
Applicant Contact JAMES C STANGE
Correspondent
The Devilbiss Co.
P.O. Box 635
Somerset,  PA  15501
Correspondent Contact JAMES C STANGE
Regulation Number868.5640
Classification Product Code
CCQ  
Date Received11/12/1985
Decision Date 12/09/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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