The following data is part of a premarket notification filed by Remel Co. with the FDA for Zinc Pva.
| Device ID | K931383 |
| 510k Number | K931383 |
| Device Name: | ZINC PVA |
| Classification | Device, Specimen Collection |
| Applicant | REMEL CO. 12076 SANTA FE DR. Lenexa, KS 66215 |
| Contact | Ann Silvius |
| Correspondent | Ann Silvius REMEL CO. 12076 SANTA FE DR. Lenexa, KS 66215 |
| Product Code | LIO |
| CFR Regulation Number | 866.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-18 |
| Decision Date | 1993-06-15 |