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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 K911589
Device Name DISPOSABLE SURGICAL TROCAR WITH SEAL
Applicant
Applied Vascular Devices, Inc.
26051 Merit Cir., #104
Laguna Hills,  CA  92653
Applicant Contact JO STEGWELL
Correspondent
Applied Vascular Devices, Inc.
26051 Merit Cir., #104
Laguna Hills,  CA  92653
Correspondent Contact JO STEGWELL
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received04/09/1991
Decision Date 07/05/1991
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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