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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubing, Fluid Delivery
510(k) Number K873852
Device Name INFUSION MANIFOLD
Applicant
Advanced Surgical Products, Inc.
744 Goddard
Chesterfield,  MO  63017
Applicant Contact TODD J HESSEL
Correspondent
Advanced Surgical Products, Inc.
744 Goddard
Chesterfield,  MO  63017
Correspondent Contact TODD J HESSEL
Regulation Number880.5440
Classification Product Code
FPK  
Date Received09/22/1987
Decision Date 11/23/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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