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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K895075
Device Name ACCI-GUARD REUSABLE HOLDER
Applicant
Medical Safety Products, Inc.
2696 S. Colorado Blvd., Suite
585
Denver,  CO  80222
Applicant Contact WILLIAM SAGSTETTER
Correspondent
Medical Safety Products, Inc.
2696 S. Colorado Blvd., Suite
585
Denver,  CO  80222
Correspondent Contact WILLIAM SAGSTETTER
Regulation Number880.5570
Classification Product Code
FMI  
Date Received08/14/1989
Decision Date 10/31/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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