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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name endoscopic access overtube, gastroenterology-urology
510(k) Number K896680
Device Name PROBE SHEATH FOR ADMS & CAPISTRANO LABS TRANSREC.
Applicant
INTERSON CORP.
7068 KOLL CENTER PKWY., #415
PLEASANTON,  CA  94566
Applicant Contact MARK F HAYWARD
Correspondent
INTERSON CORP.
7068 KOLL CENTER PKWY., #415
PLEASANTON,  CA  94566
Correspondent Contact MARK F HAYWARD
Regulation Number876.1500
Classification Product Code
FED  
Date Received11/27/1989
Decision Date 02/14/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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