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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 K936029
Device Name NON-CORNING (HUBER) NEEDLE
Applicant
Therex Corp.
1600 Providence Hwy.
Walpole,  MA  02081
Applicant Contact BRADLEY J ENEGREN
Correspondent
Therex Corp.
1600 Providence Hwy.
Walpole,  MA  02081
Correspondent Contact BRADLEY J ENEGREN
Regulation Number880.5570
Classification Product Code
FMI  
Date Received12/17/1993
Decision Date 02/04/1994
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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