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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 K880262
Device Name MOBILE PAK, MODEL DC
Applicant
Intl. Biomedical Concepts, Inc.
2955 S. Tejon
Englewood,  CO  80110
Applicant Contact GEORGI, III
Correspondent
Intl. Biomedical Concepts, Inc.
2955 S. Tejon
Englewood,  CO  80110
Correspondent Contact GEORGI, III
Regulation Number868.5440
Classification Product Code
CAW  
Date Received01/22/1988
Decision Date 02/12/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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