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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K974771
Device Name STRYKER SE5 ARTHROSCOPY SYSTEM WITH HERMES VOICE CONTROL
Applicant
Stryker Endoscopy
2590 Walsh Ave.
Santa Clara,  CA  95051
Applicant Contact SALMAAN HAMEED
Correspondent
Stryker Endoscopy
2590 Walsh Ave.
Santa Clara,  CA  95051
Correspondent Contact SALMAAN HAMEED
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received12/22/1997
Decision Date 05/29/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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