510(k) K973587
K973587 is an FDA 510(k) premarket notification submitted by Exmoor Plastics , Ltd. for the device "EXMOOR TYMPANOCENTESIS KIT (TK/1)". The FDA issued a decision of Substantially Equivalent on January 23, 1998. The device falls under product code JZF (Tube, Ear Suction), a Class I device regulated under 21 CFR 874.4420. Exmoor Plastics , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 23, 1998
- Date Received
- September 22, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Ear Suction
- Device Class
- Class I
- Regulation Number
- 874.4420
- Review Panel
- EN
- Submission Type