510(k) K943281
K943281 is an FDA 510(k) premarket notification submitted by Micromed Development Corp. for the device "POLYETHYLENE VENT TUBES". The FDA issued a decision of Substantially Equivalent on August 24, 1994. The device falls under product code ETD (Tube, Tympanostomy), a Class II device regulated under 21 CFR 874.3880. Micromed Development Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 24, 1994
- Date Received
- July 7, 1994
- Clearance Type
- Traditional
- 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