The following data is part of a premarket notification filed by J.f. Jelenko & Co., Inc. with the FDA for Eureka Plus.
Device ID | K944887 |
510k Number | K944887 |
Device Name: | EUREKA PLUS |
Classification | Alloy, Gold-based Noble Metal |
Applicant | J.F. JELENKO & CO., INC. 99 BUSINESS PARK DR. Armonk, NY 10504 |
Contact | Paul J Cascone |
Correspondent | Paul J Cascone J.F. JELENKO & CO., INC. 99 BUSINESS PARK DR. Armonk, NY 10504 |
Product Code | EJT |
CFR Regulation Number | 872.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-10-04 |
Decision Date | 1994-11-07 |