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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 K901340
Device Name MODEL MC 2100 ND:YAG SURGICAL LASER SYSTEM
Applicant
Klinger Medical
27812 Ruisenor
Mission Viejo,  CA  92691
Applicant Contact MICHAEL MORETTI
Correspondent
Klinger Medical
27812 Ruisenor
Mission Viejo,  CA  92691
Correspondent Contact MICHAEL MORETTI
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/22/1990
Decision Date 06/26/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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