510(k) K073127

BLOOD COLLECTION NEEDLE, MODEL 20G 21G 22G by Shandong Weigao Group Medical Polymer Co., Ltd. — Product Code FMI

K073127 is an FDA 510(k) premarket notification submitted by Shandong Weigao Group Medical Polymer Co., Ltd. for the device "BLOOD COLLECTION NEEDLE, MODEL 20G 21G 22G". The FDA issued a decision of Substantially Equivalent on Dec 20, 2007. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Shandong Weigao Group Medical Polymer Co., Ltd. has 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 20, 2007
Date Received
Nov 6, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type
510(k)