510(k) K030853
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 21, 2003
- Date Received
- March 18, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wrap, Sterilization
- Device Class
- Class II
- Regulation Number
- 880.6850
- Review Panel
- HO
- Submission Type