510(k) K874342
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 13, 1987
- Date Received
- October 20, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Carrier, Ligature
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type