510(k) K862903
K862903 is an FDA 510(k) premarket notification submitted by Steven K. Juhn for the device "MIDDLE EAR VIEWER AND FLUID COLLECTOR". The FDA issued a decision of Substantially Equivalent on November 24, 1986. The device falls under product code JZF (Tube, Ear Suction), a Class I device regulated under 21 CFR 874.4420.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 24, 1986
- Date Received
- July 31, 1986
- 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