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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Nasal, Oxygen
510(k) Number K860535
Device Name UNILATERAL OXYGEN DELIVERY SYSTEM (ULODS)
Applicant
Andover Medical, Inc.
23 Ballard Way
Lawrence,  MA  01843
Applicant Contact JOHN F CAVALLARO
Correspondent
Andover Medical, Inc.
23 Ballard Way
Lawrence,  MA  01843
Correspondent Contact JOHN F CAVALLARO
Regulation Number868.5340
Classification Product Code
CAT  
Date Received02/12/1986
Decision Date 04/01/1986
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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