510(k) K992553
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 12, 2000
- Date Received
- July 30, 1999
- 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