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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 K911817
Device Name ENDOSCOPIC CLIP APPLIER
Applicant
Surgitech C/O Collier, Shannon, Rill & Scott
6006-B Triangle Dr.
Raleigh,  NC  27612
Applicant Contact LEON SUBSTELY
Correspondent
Surgitech C/O Collier, Shannon, Rill & Scott
6006-B Triangle Dr.
Raleigh,  NC  27612
Correspondent Contact LEON SUBSTELY
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received04/24/1991
Decision Date 06/11/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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