510(k) K803155
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 8, 1981
- Date Received
- December 12, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cup, Prophylaxis
- Device Class
- Class I
- Regulation Number
- 872.6290
- Review Panel
- DE
- Submission Type