510(k) K964256
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 6, 1997
- Date Received
- October 25, 1996
- 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