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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 K844312
Device Name ME-TOO OXYGEN CONCENTRATOR
Applicant
MEDEQUIP CO.
27 KEENEY AVE.
WEST HARTFORD,  CT  06107
Applicant Contact FRANCES X HURSEY
Correspondent
MEDEQUIP CO.
27 KEENEY AVE.
WEST HARTFORD,  CT  06107
Correspondent Contact FRANCES X HURSEY
Regulation Number868.5440
Classification Product Code
CAW  
Date Received11/06/1984
Decision Date 12/24/1984
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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