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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 K132665
Device Name PELLEVE GLIDESAFE 10MM, 15MM & 20MM HANDPIECE, PELLEVE S5 - IEC
Applicant
Ellman International, Inc.
400 Karin Ln.
Hicksville,  NY  11801
Applicant Contact Alison Sathe
Correspondent
Ellman International, Inc.
400 Karin Ln.
Hicksville,  NY  11801
Correspondent Contact Alison Sathe
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/27/2013
Decision Date 09/25/2013
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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