The following data is part of a premarket notification filed by Jeneric Ind. with the FDA for Rexillium N. B. F..
Device ID | K862822 |
510k Number | K862822 |
Device Name: | REXILLIUM N. B. F. |
Classification | Alloy, Metal, Base |
Applicant | JENERIC IND. 125 NORTH PLAINS INDUST. RD. P.O. BOX 724 Wallingford, CT 06492 |
Contact | Martin L Schulman |
Correspondent | Martin L Schulman JENERIC IND. 125 NORTH PLAINS INDUST. RD. P.O. BOX 724 Wallingford, CT 06492 |
Product Code | EJH |
CFR Regulation Number | 872.3710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-07-25 |
Decision Date | 1986-09-02 |