510(k) K951228
K951228 is an FDA 510(k) premarket notification submitted by U.S. Table, Inc. for the device "ASH-7000". The FDA issued a decision of Substantially Equivalent on May 17, 1995. The device falls under product code ITH (Equipment, Traction, Powered), a Class II device regulated under 21 CFR 890.5900. U.S. Table, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 17, 1995
- Date Received
- March 20, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Equipment, Traction, Powered
- Device Class
- Class II
- Regulation Number
- 890.5900
- Review Panel
- PM
- Submission Type