510(k) K120728
K120728 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "PHASIX PLUG AND PATCH". The FDA issued a decision of Substantially Equivalent on October 22, 2012. The device falls under product code OWT (Mesh, Surgical, Absorbable, Abdominal Hernia), a Class II device regulated under 21 CFR 878.3300. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 22, 2012
- Date Received
- March 9, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical, Absorbable, Abdominal Hernia
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type
For reinforcement of soft tissue where weakness exists during hernia repair.