510(k) K904821
K904821 is an FDA 510(k) premarket notification submitted by Hood Laboratories for the device "ELIACHAR MODIFIED ESOPHAGEAL STENT". The FDA issued a decision of Substantially Equivalent on January 14, 1991. The device falls under product code ESW (Prosthesis, Esophageal), a Class II device regulated under 21 CFR 878.3610. Hood Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 14, 1991
- Date Received
- October 24, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Esophageal
- Device Class
- Class II
- Regulation Number
- 878.3610
- Review Panel
- GU
- Submission Type