510(k) K102328
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)