510(k) K963391
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 12, 1997
- Date Received
- August 28, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Source, Chemiluminescent Light
- Device Class
- Class II
- Regulation Number
- 884.4530
- Review Panel
- OB
- Submission Type