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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, liquid-oxygen, portable
510(k) Number K963956
Device Name PORTABLE LIQUID OXYGEN UNIT AND STATIONARY LIQUID OXYGEN UNIT
Applicant
SOUTHERN RESEARCH, INC.
55 NORTHERN BLVD., SUITE 140
GREAT NECK,  NY  11021
Applicant Contact SUSAN D GOLDSTEIN-FALK
Correspondent
SOUTHERN RESEARCH, INC.
55 NORTHERN BLVD., SUITE 140
GREAT NECK,  NY  11021
Correspondent Contact SUSAN D GOLDSTEIN-FALK
Regulation Number868.5655
Classification Product Code
BYJ  
Date Received10/02/1996
Decision Date 12/09/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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