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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 K933345
Device Name NOBLES-LAI ENDOSCOPIC/LAPAROSCOPIC
Applicant
NOBLES-LAI ENGINEERING, INC.
COLUMBIA SQUARE
555 THIRTEENTH STREET, NW
washington,  DC  20004 -1109
Applicant Contact jonathan s kahan
Correspondent
NOBLES-LAI ENGINEERING, INC.
COLUMBIA SQUARE
555 THIRTEENTH STREET, NW
washington,  DC  20004 -1109
Correspondent Contact jonathan s kahan
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received07/09/1993
Decision Date 02/22/1994
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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