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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name illuminator, fiberoptic, surgical field
510(k) Number K890398
Device Name RYAN-STYLE DIRECTED INFUSION MANIPULATOR
Applicant
ADVANCED SURGICAL PRODUCTS, INC.
750 GODDARD AVE.
CHESTERFIELD,  MO  63005
Applicant Contact TODD J HESSEL
Correspondent
ADVANCED SURGICAL PRODUCTS, INC.
750 GODDARD AVE.
CHESTERFIELD,  MO  63005
Correspondent Contact TODD J HESSEL
Regulation Number878.4580
Classification Product Code
HBI  
Date Received01/24/1989
Decision Date 02/17/1989
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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