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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 K823506
Device Name NASAL CANNULA
Applicant
SEVEN HARVEST INTL. IMPORT & EXPORT
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
SEVEN HARVEST INTL. IMPORT & EXPORT
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5340
Classification Product Code
CAT  
Date Received11/24/1982
Decision Date 12/09/1982
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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