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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 K926110
Device Name ASI LIGASURE(TM) SUTURE LIGATION INSTRUMENT
Applicant
Advanced Surgical Intervention, Inc.
951 Calle Amanecer
San Clemente,  CA  92672
Applicant Contact JAY LENKER
Correspondent
Advanced Surgical Intervention, Inc.
951 Calle Amanecer
San Clemente,  CA  92672
Correspondent Contact JAY LENKER
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received12/03/1992
Decision Date 07/08/1993
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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