The following data is part of a premarket notification filed by Tecnol New Jersey Wound Care, Inc. with the FDA for O.r. Armboard Cover.
| Device ID | K813030 |
| 510k Number | K813030 |
| Device Name: | O.R. ARMBOARD COVER |
| Classification | Operating Room Accessories Table Tray |
| Applicant | TECNOL NEW JERSEY WOUND CARE, INC. 368 FAIRVIEW AVE. Hammonton, NJ 08037 -0268 |
| Product Code | FWZ |
| CFR Regulation Number | 878.4950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-28 |
| Decision Date | 1982-01-18 |