510(k) K853589
K853589 is an FDA 510(k) premarket notification submitted by Downs Surgical , Ltd. for the device "SHAH SELF-CLEARING MASTOID SUCTION TUBE". The FDA issued a decision of Substantially Equivalent on December 23, 1985. The device falls under product code JZF (Tube, Ear Suction), a Class I device regulated under 21 CFR 874.4420. Downs Surgical , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 23, 1985
- Date Received
- August 27, 1985
- 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