510(k) K860503
K860503 is an FDA 510(k) premarket notification submitted by Porex Medical for the device "THE POREX RETRACTOR TABLE". The FDA issued a decision of Substantially Equivalent on March 13, 1986. The device falls under product code FSE (Table, Operating-Room, Manual), a Class I device regulated under 21 CFR 878.4950. Porex Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 13, 1986
- Date Received
- February 11, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Table, Operating-Room, Manual
- Device Class
- Class I
- Regulation Number
- 878.4950
- Review Panel
- SU
- Submission Type