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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 K103375
Device Name PLUMEPEN INTEGRATED SMOKE EVACUATION PENCIL
Applicant
Medtek Devices, Inc.
595 Commerce Dr.
Buffalo,  NY  14228
Applicant Contact GREG PEPE
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/16/2010
Decision Date 03/16/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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