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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 K830242
Device Name MICRO 2 HYPODERMIC NEEDLES
Applicant
SMITH & NEPHEW, MPL DIVISION
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
SMITH & NEPHEW, MPL DIVISION
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.5570
Classification Product Code
FMI  
Date Received01/25/1983
Decision Date 02/15/1983
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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