510(k) K810900
K810900 is an FDA 510(k) premarket notification submitted by Sybron Corp. for the device "CASTLE PROCEDURE AND RITTER EXAM. TABLES". The FDA issued a decision of Substantially Equivalent on April 21, 1981. The device falls under product code LGX (Table, Examination, Medical, Powered), a Class I device regulated under 21 CFR 878.4960. Sybron Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 21, 1981
- Date Received
- April 3, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Table, Examination, Medical, Powered
- Device Class
- Class I
- Regulation Number
- 878.4960
- Review Panel
- HO
- Submission Type