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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 K801839
Device Name DISPOSABLE HYPODERMIC NEEDLES
Applicant
Martin'S Maine Exchange
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Martin'S Maine Exchange
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5570
Classification Product Code
FMI  
Date Received08/01/1980
Decision Date 09/16/1980
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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