The following data is part of a premarket notification filed by Jeneric/pentron, Inc. with the FDA for R2+.
| Device ID | K934758 |
| 510k Number | K934758 |
| Device Name: | R2+ |
| Classification | Alloy, Metal, Base |
| Applicant | JENERIC/PENTRON, INC. 53 NORTH PLAINS INDUSTRIAL ROAD Wallingford, CT 06492 -0724 |
| Contact | Linda Leduc |
| Correspondent | Linda Leduc JENERIC/PENTRON, INC. 53 NORTH PLAINS INDUSTRIAL ROAD Wallingford, CT 06492 -0724 |
| Product Code | EJH |
| CFR Regulation Number | 872.3710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-04 |
| Decision Date | 1994-02-18 |