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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
Applicant Contact GRIFFIN
Correspondent
ASSIST FILL, LLC
55 NORTHERN BLVD
STE 200
GREAT NECK,  NY  11021
Correspondent Contact GRIFFIN
Regulation Number890.5050
Classification Product Code
PCM  
Date Received06/05/2012
Decision Date 12/27/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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