The following data is part of a premarket notification filed by Jeneric/pentron, Inc. with the FDA for Jewel Cast Iii.
Device ID | K003037 |
510k Number | K003037 |
Device Name: | JEWEL CAST III |
Classification | Alloy, Metal, Base |
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 | EJH |
CFR Regulation Number | 872.3710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-09-29 |
Decision Date | 2000-12-05 |