510(k) K895242
K895242 is an FDA 510(k) premarket notification submitted by Richards Medical Co., Inc. for the device "PAPPAS TRI-FLANGE VENTILATION TUBE". The FDA issued a decision of Substantially Equivalent on November 17, 1989. The device falls under product code ETD (Tube, Tympanostomy), a Class II device regulated under 21 CFR 874.3880. Richards Medical Co., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 17, 1989
- Date Received
- August 21, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Tympanostomy
- Device Class
- Class II
- Regulation Number
- 874.3880
- Review Panel
- EN
- Submission Type