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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Block, Bite
510(k) Number K800369
Device Name TRI PAC MOUTH PROP
Applicant
OXEQUIP HEALTH IND.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
OXEQUIP HEALTH IND.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number882.5070
Classification Product Code
JXL  
Date Received02/20/1980
Decision Date 02/28/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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