The following data is part of a premarket notification filed by Jeneric/pentron, Inc. with the FDA for Opc Lowwear Porcelain.
| Device ID | K982377 |
| 510k Number | K982377 |
| Device Name: | OPC LOWWEAR PORCELAIN |
| Classification | Powder, Porcelain |
| Applicant | JENERIC/PENTRON, INC. 53 NORTH PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford, CT 06492 -0724 |
| Contact | Murray G Gamberg |
| Correspondent | Murray G Gamberg JENERIC/PENTRON, INC. 53 NORTH PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford, CT 06492 -0724 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-08 |
| Decision Date | 1998-08-18 |