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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K864296
Device Name S.C.T. MULTI PORT, INJECTION SITE
Applicant
Salt Creek Medical Technologies
5509 Middletown Rd.
Canfield,  OH  44406
Applicant Contact HOWARD MEADE
Correspondent
Salt Creek Medical Technologies
5509 Middletown Rd.
Canfield,  OH  44406
Correspondent Contact HOWARD MEADE
Regulation Number880.5440
Classification Product Code
FPA  
Date Received10/31/1986
Decision Date 03/02/1987
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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