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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 K890567
Device Name BITE BLOCK #59430
Applicant
MEDI-SOURCE, INC.
50 GORDON DR.
P.O. BOX 874
SYOSSET,  NY  11791
Applicant Contact ANDREW GALAMBOS
Correspondent
MEDI-SOURCE, INC.
50 GORDON DR.
P.O. BOX 874
SYOSSET,  NY  11791
Correspondent Contact ANDREW GALAMBOS
Regulation Number882.5070
Classification Product Code
JXL  
Date Received02/06/1989
Decision Date 02/17/1989
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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