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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 K813648
Device Name JMS NEEDLE & MAC JECT
Applicant
Philadelphia Biologics Center
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Philadelphia Biologics Center
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5570
Classification Product Code
FMI  
Date Received12/31/1981
Decision Date 01/28/1982
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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