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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 K003151
Device Name MICROPOBE SERIES OF LASERS AND ACCESSORIES
Applicant
ENDO OPTIKS, INC.
39 SYCAMORE AVE.
LITTLE SILVER,  NJ  07739 -1208
Applicant Contact KEITH HERTZ
Correspondent
ENDO OPTIKS, INC.
39 SYCAMORE AVE.
LITTLE SILVER,  NJ  07739 -1208
Correspondent Contact KEITH HERTZ
Regulation Number878.4810
Classification Product Code
GEX  
Date Received10/10/2000
Decision Date 01/08/2001
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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