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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name generator, oxygen, portable
510(k) Number K952268
Device Name MODEL DELTA, OM OXYGEN CONCENTRATOR
Applicant
CAIRE, INC.
10488 WEST CENTENNIAL RD.
LITTLETON,  CO  80127
Applicant Contact LINDA CHJAPMAN
Correspondent
CAIRE, INC.
10488 WEST CENTENNIAL RD.
LITTLETON,  CO  80127
Correspondent Contact LINDA CHJAPMAN
Regulation Number868.5440
Classification Product Code
CAW  
Date Received05/15/1995
Decision Date 08/11/1995
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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