510(k) K955616
K955616 is an FDA 510(k) premarket notification submitted by Misten Medical Corp. for the device "MISTEN MEDICAL REUTER BOBBIN STYLE VENT TUBE". The FDA issued a decision of Substantially Equivalent on January 17, 1996. The device falls under product code ETD (Tube, Tympanostomy), a Class II device regulated under 21 CFR 874.3880. Misten Medical Corp. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 17, 1996
- Date Received
- December 11, 1995
- 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