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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 K964128
Device Name MCL 29 DERMABLATE ERBIUM LASER SYSTEM
Applicant
Aesculap-Meditec GmbH
23832 Via Monte
Coto De Caza,  CA  92679 -4001
Applicant Contact WILLIAM T KELLEY
Correspondent
Aesculap-Meditec GmbH
23832 Via Monte
Coto De Caza,  CA  92679 -4001
Correspondent Contact WILLIAM T KELLEY
Regulation Number878.4810
Classification Product Code
GEX  
Date Received10/15/1996
Decision Date 03/17/1997
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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