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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Holding Chambers, Direct Patient Interface
510(k) Number K143615
Device Name Antistatic Compact Space Chamber
Applicant
Medical Developments International Limited
7/56 Smith Rd.
Springvale,  AU 3171
Applicant Contact MAGGIE OH
Correspondent
Medical Developments International Limited
7/56 Smith Rd.
Springvale,  AU 3171
Correspondent Contact MAGGIE OH
Regulation Number868.5630
Classification Product Code
NVP  
Date Received12/19/2014
Decision Date 01/26/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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