510(k) K897049
K897049 is an FDA 510(k) premarket notification submitted by Hood Laboratories for the device "GIBSON ENDOLYMPHATIC SHUNT". The FDA issued a decision of Substantially Equivalent on March 16, 1990. The device falls under product code ESZ (Tube, Shunt, Endolymphatic), a Class II device regulated under 21 CFR 874.3820. Hood Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 16, 1990
- Date Received
- December 18, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Shunt, Endolymphatic
- Device Class
- Class II
- Regulation Number
- 874.3820
- Review Panel
- EN
- Submission Type