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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 K924424
Device Name UNIMEDIX HOLMIUM FIBER
Applicant
Unimedix, Inc.
20 Drum Hill Dr.
Summit,  NJ  07901
Applicant Contact RAYMOND R BLANCHE
Correspondent
Unimedix, Inc.
20 Drum Hill Dr.
Summit,  NJ  07901
Correspondent Contact RAYMOND R BLANCHE
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/01/1992
Decision Date 04/23/1993
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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