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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 K052297
Device Name POREX ELECTROSURGERY NEEDLE
Applicant
Porex Surgical, Inc.
15 Dart Rd.
Newnan,  GA  30265
Applicant Contact ERIC V HOHENSTEIN
Correspondent
Porex Surgical, Inc.
15 Dart Rd.
Newnan,  GA  30265
Correspondent Contact ERIC V HOHENSTEIN
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
JOS  
Date Received08/23/2005
Decision Date 03/28/2006
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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