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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, nasal, oxygen
510(k) Number K800506
Device Name OXYGEN CATHETER
Applicant
MEDI-CRAFT LTD.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
MEDI-CRAFT LTD.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5350
Classification Product Code
BZB  
Date Received03/04/1980
Decision Date 03/25/1980
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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