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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 K873569
Device Name BLOOD NEEDLE HOLDER
Applicant
Sage Products, Inc.
680 Industrial Dr.
Cary,  IL  60013
Applicant Contact PAUL H HANIFL
Correspondent
Sage Products, Inc.
680 Industrial Dr.
Cary,  IL  60013
Correspondent Contact PAUL H HANIFL
Regulation Number880.5570
Classification Product Code
FMI  
Date Received09/02/1987
Decision Date 11/03/1987
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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