The following data is part of a premarket notification filed by Porex Medical with the FDA for The Porex Retractor Table.
Device ID | K860503 |
510k Number | K860503 |
Device Name: | THE POREX RETRACTOR TABLE |
Classification | Table, Operating-room, Manual |
Applicant | POREX MEDICAL 500 BOHANNON RD. Fairburn, GA 30213 |
Contact | Howard A Mercer |
Correspondent | Howard A Mercer POREX MEDICAL 500 BOHANNON RD. Fairburn, GA 30213 |
Product Code | FSE |
CFR Regulation Number | 878.4950 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-02-11 |
Decision Date | 1986-03-13 |