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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 K990414
Device Name SMITH & NEPHEW HANDPORT SYSTEM
Applicant
SMITH & NEPHEW, INC.
130 FORBES BLVD.
MANSFIELD,  MA  02048
Applicant Contact AMY L WALTERS
Correspondent
SMITH & NEPHEW, INC.
130 FORBES BLVD.
MANSFIELD,  MA  02048
Correspondent Contact AMY L WALTERS
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received02/10/1999
Decision Date 04/14/1999
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
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