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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 K924304
Device Name BITE BLOCK
Applicant
UNITED STATES ENDOSCOPY GROUP, INC.
9905 HOBART RD.
WAITE HILL,  OH  44094
Applicant Contact LISA SCHOLZ
Correspondent
UNITED STATES ENDOSCOPY GROUP, INC.
9905 HOBART RD.
WAITE HILL,  OH  44094
Correspondent Contact LISA SCHOLZ
Regulation Number882.5070
Classification Product Code
JXL  
Date Received08/26/1992
Decision Date 04/06/1993
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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