510(k) K102328

BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULA by Shandong Weigao Group Medical Polymer Co., Ltd. — Product Code FMI

K102328 is an FDA 510(k) premarket notification submitted by Shandong Weigao Group Medical Polymer Co., Ltd. for the device "BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULA". The FDA issued a decision of Substantially Equivalent on May 13, 2011. 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
May 13, 2011
Date Received
Aug 17, 2010
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)