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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
Applicant Contact SEAN CAHILL
Correspondent
Stryker Endoscopy
2590 Walsh Ave.
Santa Clara,  CA  95051
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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