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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K851695
Device Name ULTRA-NEB 100 ULTRASONIC NEBULIZER
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
Date Received04/22/1985
Decision Date 06/05/1985
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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