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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 K022327
Device Name NOVUS SPECTRA
Applicant
LUMENIS, INC.
3959 WEST 1820 SOUTH
SALT LAKE CITY,  UT  84104
Applicant Contact KELLY MOHROR
Correspondent
LUMENIS, INC.
3959 WEST 1820 SOUTH
SALT LAKE CITY,  UT  84104
Correspondent Contact KELLY MOHROR
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/18/2002
Decision Date 10/16/2002
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
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