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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stand, Infusion
510(k) Number K850671
Device Name IMPACT 901 SERIES PORT-A-WALL
Applicant
Impact Instrumentation, Inc.
P.O. Box 412
Bogota,  NJ  07603
Applicant Contact LESLIE H SHERMAN
Correspondent
Impact Instrumentation, Inc.
P.O. Box 412
Bogota,  NJ  07603
Correspondent Contact LESLIE H SHERMAN
Regulation Number880.6990
Classification Product Code
FOX  
Date Received02/20/1985
Decision Date 03/11/1985
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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