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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name portable liquid oxygen unit stand
510(K) Number K121661
Device Name EZ-ASSIST-FILL
Applicant
ASSIST FILL, LLC
55 northern blvd
ste 200
great neck,  NY  11021
Contact griffin
Regulation Number890.5050
Classification Product Code
PCM  
Date Received06/05/2012
Decision Date 12/27/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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