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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 K854509
Device Name TRAVELPAK MODEL AC-102
Applicant
Travomed, Inc.
2144 N. Beltline
Suite J
Mesquite,  TX  75150
Applicant Contact BEN MILCAREK
Correspondent
Travomed, Inc.
2144 N. Beltline
Suite J
Mesquite,  TX  75150
Correspondent Contact BEN MILCAREK
Regulation Number868.5440
Classification Product Code
CAW  
Date Received11/12/1985
Decision Date 01/28/1986
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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