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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 K122252
Device Name SPACE CHAMBER PLUS COMPACT SPACE CHAMBER PLUS
Applicant
MEDICAL DEVELOPMENTS INTERNATIONAL
SUITE 408, 460 PACIFIC HIGHWAY
ST LEONARDS,  AU 2065
Applicant Contact TRACEY BULLIVANT
Correspondent
MEDICAL DEVELOPMENTS INTERNATIONAL
SUITE 408, 460 PACIFIC HIGHWAY
ST LEONARDS,  AU 2065
Correspondent Contact TRACEY BULLIVANT
Regulation Number868.5630
Classification Product Code
NVP  
Date Received07/27/2012
Decision Date 11/13/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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