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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Attachment, Binocular, For Endoscope
510(k) Number K840837
Device Name TBI TRAINER
Applicant
Manico
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Manico
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number876.1500
Classification Product Code
FEJ  
Date Received02/24/1984
Decision Date 03/25/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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