510(k) K841357
K841357 is an FDA 510(k) premarket notification submitted by Treace Medical, Inc. for the device "MICRO FLUID APPLICATOR". The FDA issued a decision of Substantially Equivalent on August 24, 1984. The device falls under product code JZF (Tube, Ear Suction), a Class I device regulated under 21 CFR 874.4420. Treace Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 24, 1984
- Date Received
- April 2, 1984
- 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