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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Operating-Room, Ac-Powered
510(k) Number K936308
Device Name ENDEX ENDOSCOPIC POSITIONING SYSTEM
Applicant
Andronic Devices, Ltd.
Suite 140
13120 Vanier Pl.
Richmond, B.C. Canada V6v 2j2,  CA V6V 2J2
Applicant Contact ROBERT MACNEIL
Correspondent
Andronic Devices, Ltd.
Suite 140
13120 Vanier Pl.
Richmond, B.C. Canada V6v 2j2,  CA V6V 2J2
Correspondent Contact ROBERT MACNEIL
Regulation Number878.4960
Classification Product Code
FQO  
Date Received12/20/1993
Decision Date 03/31/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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