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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Humidifier, Non-Direct Patient Interface (Home-Use)
510(k) Number K862171
Device Name MP-500 ELECTRONIC NEBULIZER
Applicant
The Timeter Group
2501 Oregon Pike
Lancaster,  PA  17601
Applicant Contact TERRY L LANDIS
Correspondent
The Timeter Group
2501 Oregon Pike
Lancaster,  PA  17601
Correspondent Contact TERRY L LANDIS
Regulation Number868.5460
Classification Product Code
KFZ  
Date Received06/09/1986
Decision Date 07/14/1986
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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