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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 K130826
Device Name PASSPORT ROBOTIC REDUCER CAP; PASSPORT STOPCOCK WITH ROTATING MALE LUER
Applicant
Stryker Endoscopy
5900 Optical Ct
SAN JOSE,  CA  95138
Applicant Contact REBECCA GOLDBERG
Correspondent
Stryker Endoscopy
5900 Optical Ct
SAN JOSE,  CA  95138
Correspondent Contact REBECCA GOLDBERG
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received03/26/2013
Decision Date 08/01/2013
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
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