510(k) K900218
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 18, 1990
- Date Received
- January 17, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Tympanostomy, Porous Polyethylene
- Device Class
- Class II
- Regulation Number
- 874.3880
- Review Panel
- EN
- Submission Type