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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 K940157
Device Name ENLINE MONOPOLAR ENDOSCOPIC SURGICAL INSTRUMENTS
Applicant
SURGIGUS INSTRUMENTS, INC.
2269 GRISSOM DR.
MARYLAND HEIGHTS,  MO  63146
Applicant Contact JOE PRESSWOOD
Correspondent
SURGIGUS INSTRUMENTS, INC.
2269 GRISSOM DR.
MARYLAND HEIGHTS,  MO  63146
Correspondent Contact JOE PRESSWOOD
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received01/03/1994
Decision Date 04/25/1994
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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