510(k) K861298
K861298 is an FDA 510(k) premarket notification submitted by Jedmed Instrument Co. for the device "FISCH DRILL IRRIGATOR". The FDA issued a decision of Substantially Equivalent on April 23, 1986. The device falls under product code KAR (Irrigator, Sinus), a Class I device regulated under 21 CFR 874.4420. Jedmed Instrument Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 23, 1986
- Date Received
- April 7, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Irrigator, Sinus
- Device Class
- Class I
- Regulation Number
- 874.4420
- Review Panel
- EN
- Submission Type