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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 K894211
Device Name SHARPLAN SERIES 2900 SYNTHETIC CONTACT TIPS
Applicant
SHARPLAN LASERS, INC.
columbia square
555 thirteenth street nw
washington,  DC  20004
Applicant Contact jonathan kohan
Correspondent
SHARPLAN LASERS, INC.
columbia square
555 thirteenth street nw
washington,  DC  20004
Correspodent Contact jonathan kohan
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/19/1989
Decision Date 08/10/1989
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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