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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Laparoscopic
510(k) Number K934928
Device Name INSITE FILTER & TUBING SET
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 Number884.1730
Classification Product Code
HIF  
Date Received10/14/1993
Decision Date 05/26/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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