510(k) K951419
K951419 is an FDA 510(k) premarket notification submitted by U.S. Table, Inc. for the device "FLEX D-4000". The FDA issued a decision of Substantially Equivalent on June 30, 1995. The device falls under product code INQ (Table, Powered), a Class I device regulated under 21 CFR 890.3760. U.S. Table, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 30, 1995
- Date Received
- March 28, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Table, Powered
- Device Class
- Class I
- Regulation Number
- 890.3760
- Review Panel
- PM
- Submission Type