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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K083754
Device Name MINI LAP ELECTROCAUTERY INSTRUMENTS
Applicant
Mini Lap Technologies, Inc.
80 Shelton Technology Ctr
Shelton,  CT  06484
Applicant Contact JOSEPH AZARY
Correspondent
Mini Lap Technologies, Inc.
80 Shelton Technology Ctr
Shelton,  CT  06484
Correspondent Contact JOSEPH AZARY
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/17/2008
Decision Date 11/20/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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