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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 K152317
Device Name Stretta Catheter
800 Connecticut Ave, 1E01
Norwalk,  CT  06854
Applicant Contact Oleg Shikhman
Lakeshore Medical Device Consulting, LLC
128 Blye Hill Landing
Newbury,  NH  03255
Correspondent Contact Michele Lucey
Regulation Number878.4400
Classification Product Code
Date Received08/17/2015
Decision Date 09/23/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls