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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Oxygen, Gaseous-Phase
510(k) Number K811702
Device Name MODEL 381 HOME OXYGEN SENTRY
Applicant
STANLEY AVIATION CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
STANLEY AVIATION CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.1720
Classification Product Code
CCL  
Date Received06/16/1981
Decision Date 07/16/1981
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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