510(k) K020132
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 26, 2002
- Date Received
- January 15, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
- Device Class
- Class II
- Regulation Number
- 870.3470
- Review Panel
- CV
- Submission Type