510(k) K121898
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 24, 2013
- Date Received
- June 29, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fiber, Medical, Absorbent
- Device Class
- Class I
- Regulation Number
- 880.5300
- Review Panel
- HO
- Submission Type