510(k) K860503

THE POREX RETRACTOR TABLE by Porex Medical — Product Code FSE

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