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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
Predetermined Change
Control Plan Authorized		 No
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