510(k) K063005
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 23, 2007
- Date Received
- October 2, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gown, Surgical
- Device Class
- Class II
- Regulation Number
- 878.4040
- Review Panel
- HO
- Submission Type