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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 K014301
Device Name MODIFICATION TO MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS
Applicant
MERITS HEALTH PRODUCTS CO., LTD.
7690 CAMERON CIRCLE
FORT MYERS,  FL  33912
Applicant Contact Lee Leichter
Correspondent
MERITS HEALTH PRODUCTS CO., LTD.
7690 CAMERON CIRCLE
FORT MYERS,  FL  33912
Correspondent Contact Lee Leichter
Regulation Number868.5440
Classification Product Code
CAW  
Date Received12/31/2001
Decision Date 02/11/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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