510(k) K052018
K052018 is an FDA 510(k) premarket notification submitted by Miltex, Inc. for the device "MILTEX LIGATING CLIP". The FDA issued a decision of Substantially Equivalent on November 4, 2005. The device falls under product code FZP (Clip, Implantable), a Class II device regulated under 21 CFR 878.4300. Miltex, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 4, 2005
- Date Received
- July 26, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clip, Implantable
- Device Class
- Class II
- Regulation Number
- 878.4300
- Review Panel
- SU
- Submission Type