510(k) K011383
K011383 is an FDA 510(k) premarket notification submitted by Durect Corp. for the device "MICRODOSE CATH, MODELS 90121-201, -202, -203". The FDA issued a decision of Substantially Equivalent on June 25, 2001. The device falls under product code ETD (Tube, Tympanostomy), a Class II device regulated under 21 CFR 874.3880.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 25, 2001
- Date Received
- May 7, 2001
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Tympanostomy
- Device Class
- Class II
- Regulation Number
- 874.3880
- Review Panel
- EN
- Submission Type