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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 K820911
Device Name PBC NEEDLE BY NIPRO MED. INDUSTRIES
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 Received04/01/1982
Decision Date 04/15/1982
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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