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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Guide, Drill, Ligament
510(k) Number K910712
Device Name VILLAN (VIDEO LIFT LINK ANALYSIS)
Applicant
Physio Systems, Inc.
4450 Enterprise St. Suite 101
Fremont,  CA  94538
Applicant Contact DAVID E LEIBERMAN
Correspondent
Physio Systems, Inc.
4450 Enterprise St. Suite 101
Fremont,  CA  94538
Correspondent Contact DAVID E LEIBERMAN
Regulation Number878.4820
Classification Product Code
LXI  
Date Received02/20/1991
Decision Date 05/21/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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