The following data is part of a premarket notification filed by Jeneric/pentron, Inc. with the FDA for Correct Plus.
| Device ID | K001218 |
| 510k Number | K001218 |
| Device Name: | CORRECT PLUS |
| Classification | Material, Impression |
| Applicant | JENERIC/PENTRON, INC. 53 NORTH PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford, CT 06492 -0724 |
| Contact | Annmarie Tenero |
| Correspondent | Annmarie Tenero JENERIC/PENTRON, INC. 53 NORTH PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford, CT 06492 -0724 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-17 |
| Decision Date | 2000-07-05 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CORRECT PLUS 78068622 2586690 Live/Registered |
Jeneric/Pentron, Incorporated 2001-06-12 |