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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 K033132
Device Name STRYKER SWITCHPOINT INFINITY
Applicant
STRYKER COMMUNICATIONS CORP.
12140 COMMUNITY ROAD
POWAY,  CA  92020
Applicant Contact NATHAN WOODCOCK
Correspondent
STRYKER COMMUNICATIONS CORP.
12140 COMMUNITY ROAD
POWAY,  CA  92020
Correspondent Contact NATHAN WOODCOCK
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received09/30/2003
Decision Date 09/02/2004
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
Recalls CDRH Recalls
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