510(k) K042380
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 25, 2004
- Date Received
- September 1, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Elastomer, Silicone Block
- Device Class
- Class II
- Regulation Number
- 874.3620
- Review Panel
- SU
- Submission Type