510(k) K063160
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 2006
- Date Received
- October 17, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Applicator, Absorbent Tipped, Non-Sterile
- Device Class
- Class I
- Regulation Number
- 880.6025
- Review Panel
- HO
- Submission Type