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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Aspiration And Injection, Disposable
510(k) Number K102274
Device Name ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT
Applicant
Arvik Enterprises/ Mini Lap Technologies
80 Shelton Technology Center
Shelton,  CT  06484
Applicant Contact CURTIS RAYMOND
Correspondent
Arvik Enterprises/ Mini Lap Technologies
80 Shelton Technology Center
Shelton,  CT  06484
Correspondent Contact CURTIS RAYMOND
Regulation Number878.4800
Classification Product Code
GAA  
Date Received08/11/2010
Decision Date 06/15/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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