510(k) K924713
K924713 is an FDA 510(k) premarket notification submitted by T. Korossurgical Instruments Corp. for the device "UNIVERSAL SURGICAL INSTRUMENT HOLDER". The FDA issued a decision of Substantially Equivalent on May 17, 1993. The device falls under product code FWW (Table, Operating-Room, Pneumatic), a Class I device regulated under 21 CFR 878.4960. T. Korossurgical Instruments Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 17, 1993
- Date Received
- September 18, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Table, Operating-Room, Pneumatic
- Device Class
- Class I
- Regulation Number
- 878.4960
- Review Panel
- SU
- Submission Type