510(k) K822038
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 3, 1982
- Date Received
- July 12, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orange G
- Device Class
- Class I
- Regulation Number
- 864.1850
- Review Panel
- PA
- Submission Type