510(k) K833273
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 31, 1983
- Date Received
- September 21, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Biebrich Scarlet
- Device Class
- Class I
- Regulation Number
- 864.1850
- Review Panel
- PA
- Submission Type