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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bougie, Esophageal, And Gastrointestinal, Gastro-Urology
510(k) Number K983220
Device Name STRYKER INFRAVISION ESOPHAGEAL KIT
Applicant
Stryker Endoscopy
2590 Walsh Ave.
Santa Clara,  CA  95051 -4085
Applicant Contact SEAN CAHILL
Correspondent
Stryker Endoscopy
2590 Walsh Ave.
Santa Clara,  CA  95051 -4085
Correspondent Contact SEAN CAHILL
Regulation Number876.5365
Classification Product Code
FAT  
Date Received09/14/1998
Decision Date 06/04/1999
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
Recalls CDRH Recalls
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