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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K152636
Device Name Laser Dock
Applicant
Patient Pocket, LLC
405 Hialeah Dr.
Cherry Hill,  NJ  08002
Applicant Contact ALLEN D SEFTEL
Correspondent
Licensale, Inc.
57 Lazy Brook Rd.
Monroe,  CT  06468
Correspondent Contact RAY KELLY
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/15/2015
Decision Date 12/17/2015
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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