510(k) K974008
K974008 is an FDA 510(k) premarket notification submitted by Exmoor Plastics , Ltd. for the device "PFLEIDERER'S INTRATYMPANIC CATHETER". The FDA issued a decision of Substantially Equivalent on May 13, 1998. The device falls under product code ETD (Tube, Tympanostomy), a Class II device regulated under 21 CFR 874.3880. Exmoor Plastics , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 13, 1998
- Date Received
- October 17, 1997
- 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