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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical, Antimicrobial
510(k) Number K911521
Device Name ARTHROBOT(TM) 96 (240 CM) DRAPE WITH 1 STRAP
Applicant
Andronic Devices, Ltd.
13120 Vanier Pl.
Suite 140
Richmond,B.C. V6v-2j2,  CA
Applicant Contact MICHAEL CHAN
Correspondent
Andronic Devices, Ltd.
13120 Vanier Pl.
Suite 140
Richmond,B.C. V6v-2j2,  CA
Correspondent Contact MICHAEL CHAN
Regulation Number878.4370
Classification Product Code
KKX  
Date Received04/04/1991
Decision Date 08/02/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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