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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 K870064
Device Name MOBIL-AIR
Applicant
Roman Laboratories, Inc.
3552 S. Olathe St.
Aurora,  CO  80013
Applicant Contact RAY ROMAN
Correspondent
Roman Laboratories, Inc.
3552 S. Olathe St.
Aurora,  CO  80013
Correspondent Contact RAY ROMAN
Regulation Number868.5440
Classification Product Code
CAW  
Date Received12/02/1986
Decision Date 02/11/1987
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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