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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Bite Block
510(k) Number K896691
Device Name BITE BLOCK
Applicant
Endoscopix
18907 Nordhoff 38b
Northridge,  CA  91324
Applicant Contact MICHAEL BRADBURY
Correspondent
Endoscopix
18907 Nordhoff 38b
Northridge,  CA  91324
Correspondent Contact MICHAEL BRADBURY
Regulation Number876.1500
Classification Product Code
MNK  
Date Received11/28/1989
Decision Date 02/12/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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