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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 K823172
Device Name MEDOX OXYGEN SYSTEM
Applicant
MEPECC INTL.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
MEPECC INTL.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.5440
Classification Product Code
CAW  
Date Received11/01/1982
Decision Date 02/01/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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