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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Liquid-Oxygen, Portable
510(k) Number K103324
Device Name PRECISION LIQUID OXYGEN SYSTEM
Applicant
Precision Medical, Inc.
300 Held Dr.
Northampton,  PA  18067
Applicant Contact JAMES PARKER
Correspondent
Precision Medical, Inc.
300 Held Dr.
Northampton,  PA  18067
Correspondent Contact JAMES PARKER
Regulation Number868.5655
Classification Product Code
BYJ  
Date Received11/12/2010
Decision Date 04/21/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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