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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 K060842
Device Name REVJET TURBO
Applicant
Promedic, Inc.
6329 W.Waterview Ct.
Mccordsville,  IN  46055 -9501
Applicant Contact PAUL DRYDEN
Correspondent
Promedic, Inc.
6329 W.Waterview Ct.
Mccordsville,  IN  46055 -9501
Correspondent Contact PAUL DRYDEN
Regulation Number868.5630
Classification Product Code
CAF  
Date Received03/28/2006
Decision Date 06/21/2006
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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