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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 K993815
Device Name UNI-LASER 430
Applicant
Medart Corp.
11772 Sorrento Valley Rd.
#234
San Diego,  CA  92121
Applicant Contact JAN K ENEMAERKE
Correspondent
Medart Corp.
11772 Sorrento Valley Rd.
#234
San Diego,  CA  92121
Correspondent Contact JAN K ENEMAERKE
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/10/1999
Decision Date 05/11/2000
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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