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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 K152417
Device Name Adler MicroMed Laser Surgery Fibers
Applicant
Adler Micromed, Inc.
6842 Elaine Way
San Diego,  CA  92120
Applicant Contact BRIAN CHANDLER
Correspondent
Adler Micromed, Inc.
6842 Elaine Way
San Diego,  CA  92120
Correspondent Contact BRIAN CHANDLER
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/26/2015
Decision Date 12/01/2015
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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