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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 K954352
Device Name BITE BLOCK
Applicant
UNITED STATES ENDOSCOPY GROUP, INC.
9330 PROGRESS PKWY.
MENTOR,  OH  44060
Applicant Contact GRETCHEN YOUNKER
Correspondent
UNITED STATES ENDOSCOPY GROUP, INC.
9330 PROGRESS PKWY.
MENTOR,  OH  44060
Correspondent Contact GRETCHEN YOUNKER
Regulation Number882.5070
Classification Product Code
JXL  
Date Received09/18/1995
Decision Date 01/25/1996
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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