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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 K823582
Device Name OXYGEN CONCENTRATOR UCC-100
Applicant
LINDE DIV. UNION CARBIDE CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
LINDE DIV. UNION CARBIDE CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.5440
Classification Product Code
CAW  
Date Received12/06/1982
Decision Date 01/05/1983
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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