The following data is part of a premarket notification filed by Gresco Products, Inc. with the FDA for Prilane.
| Device ID | K981524 |
| 510k Number | K981524 |
| Device Name: | PRILANE |
| Classification | Powder, Porcelain |
| Applicant | GRESCO PRODUCTS, INC. 13391 MURPHY RD. P.O. BOX 865 Stafford, TX 77477 |
| Contact | Clinton D Vaupel |
| Correspondent | Clinton D Vaupel GRESCO PRODUCTS, INC. 13391 MURPHY RD. P.O. BOX 865 Stafford, TX 77477 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-28 |
| Decision Date | 1998-07-10 |
| Summary: | summary |