510(k) K051409
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 8, 2005
- Date Received
- May 31, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stains, Chemical Solution
- Device Class
- Class I
- Regulation Number
- 864.1850
- Review Panel
- PA
- Submission Type