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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 K002032
Device Name C02 LASER MULTIPULSE
Applicant
ASCLEPION-MEDITEC AG
2525 MC GAW AVE.
IRVINE,  CA  92623 -9791
Applicant Contact WILLIAM KELLEY
Correspondent
ASCLEPION-MEDITEC AG
2525 MC GAW AVE.
IRVINE,  CA  92623 -9791
Correspondent Contact WILLIAM KELLEY
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/03/2000
Decision Date 09/11/2000
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
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