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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 K990663
Device Name INTROMIT HAND ACCESS PORT FOR HAND ASSISTED LAPAROSCOPIC SURGERY, MODEL FP880-150
Applicant
Medtech , Ltd.
555 13th St. NW
Washington,  DC  20004
Applicant Contact JONATHAN S KAHAN
Correspondent
Medtech , Ltd.
555 13th St. NW
Washington,  DC  20004
Correspondent Contact JONATHAN S KAHAN
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received03/01/1999
Decision Date 05/27/1999
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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