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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope Accessory
510(k) Number K833491
Device Name ENDO BITE BLOCK
Applicant
AMERICAN ENDOSCOPY, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
AMERICAN ENDOSCOPY, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number874.4680
Classification Product Code
KTI  
Date Received10/07/1983
Decision Date 04/25/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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