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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Retractor
510(k) Number K922626
Device Name ADEPT INSTRUMENT POSITIONING ACCESSORY
Applicant
ANDRONIC DEVICES, LTD.
13120 VANIER PL
SUITE 140
RICHMOND,B.C. V6V-2J2,  CA
Applicant Contact ROBERT MACNEIL
Correspondent
ANDRONIC DEVICES, LTD.
13120 VANIER PL
SUITE 140
RICHMOND,B.C. V6V-2J2,  CA
Correspondent Contact ROBERT MACNEIL
Regulation Number878.4800
Classification Product Code
GAD  
Date Received06/03/1992
Decision Date 10/19/1992
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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