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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K890751
Device Name ACCI-GUARD(TM) I.V. CATHETER PLACEMENT UNIT
Applicant
Medical Safety Products, Inc.
2696 S. Colorado Blvd., Suite
585
Denver,  CO  80222
Applicant Contact E SAGSTETTER
Correspondent
Medical Safety Products, Inc.
2696 S. Colorado Blvd., Suite
585
Denver,  CO  80222
Correspondent Contact E SAGSTETTER
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received02/13/1989
Decision Date 04/21/1989
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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