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 |