510(k) K924901
K924901 is an FDA 510(k) premarket notification submitted by Exmoor Plastics , Ltd. for the device "DEANS DISPOSABLE T-TUBE INSERTER". The FDA issued a decision of Substantially Equivalent on January 28, 1993. The device falls under product code JYM (Inserter, Myringotomy Tube), 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 28, 1993
- Date Received
- September 9, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Inserter, Myringotomy Tube
- Device Class
- Class I
- Regulation Number
- 874.4420
- Review Panel
- EN
- Submission Type