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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 K993045
Device Name BARIATRIC LAPAROSCOPE, MODEL 367
Applicant
Stryker Endoscopy
2590 WALSH AVE.
SANTA CLARA,  CA  95051 -4085
Applicant Contact ROBERT H DAHLA
Correspondent
Stryker Endoscopy
2590 WALSH AVE.
SANTA CLARA,  CA  95051 -4085
Correspondent Contact ROBERT H DAHLA
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received09/10/1999
Decision Date 10/27/1999
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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