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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K934097
Device Name I SIGHT 2020 ENDOSCOPIC & SURGICAL VIDEO CAMERA
Applicant
SHARPLAN LASERS, INC.
555 THIRTEENTH STREET, N.W.
WASHINGTON,  DC  20004 -1109
Applicant Contact JONATHAN S KAHAN
Correspondent
SHARPLAN LASERS, INC.
555 THIRTEENTH STREET, N.W.
WASHINGTON,  DC  20004 -1109
Correspondent Contact JONATHAN S KAHAN
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received08/23/1993
Decision Date 02/07/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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