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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 K910062
Device Name 02-10,001
Original Applicant
LASER ENGINEERING, INC.
113 cedar st.
milford,  MA  01757
Original Contact robert i rudko
Regulation Number878.4810
Classification Product Code
GEX  
Date Received01/09/1991
Decision Date 08/16/1991
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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