The following data is part of a premarket notification filed by Alimed, Inc. with the FDA for Protecta Coat Sponges.
| Device ID | K840156 |
| 510k Number | K840156 |
| Device Name: | PROTECTA COAT SPONGES |
| Classification | Table, Radiographic, Non-tilting, Powered |
| Applicant | ALIMED, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IZZ |
| CFR Regulation Number | 892.1980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-13 |
| Decision Date | 1984-03-23 |