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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 K990724
Device Name CONWAY STUART MODEL 100 IRRIGATION PUMP & ACCESSORIES
Applicant
CONWAY STUART MEDICAL, INC.
735 PALOMAR ST.
SUNNYVALE,  CA  94086
Applicant Contact THOMAS WEHMAN
Correspondent
CONWAY STUART MEDICAL, INC.
735 PALOMAR ST.
SUNNYVALE,  CA  94086
Correspondent Contact THOMAS WEHMAN
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Code
FPA  
Date Received03/05/1999
Decision Date 08/13/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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