510(k) K960756
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 29, 1997
- Date Received
- February 23, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Chamber, Oxygen, Topical, Extremity
- Device Class
- Class II
- Regulation Number
- 878.5650
- Review Panel
- SU
- Submission Type