The following data is part of a premarket notification filed by Jeneric/pentron, Inc. with the FDA for Orosphere Plus.
| Device ID | K890682 |
| 510k Number | K890682 |
| Device Name: | OROSPHERE PLUS |
| Classification | Alloy, Amalgam |
| Applicant | JENERIC/PENTRON, INC. 53 N. PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford, CT 06492 |
| Contact | Prasad, Ph.d. |
| Correspondent | Prasad, Ph.d. JENERIC/PENTRON, INC. 53 N. PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford, CT 06492 |
| Product Code | EJJ |
| CFR Regulation Number | 872.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-09 |
| Decision Date | 1989-05-05 |