The following data is part of a premarket notification filed by J.f. Jelenko & Co., Inc. with the FDA for Jelfine-52 (code Name Rd-0901).
| Device ID | K981257 |
| 510k Number | K981257 |
| Device Name: | JELFINE-52 (CODE NAME RD-0901) |
| Classification | Alloy, Other Noble Metal |
| Applicant | J.F. JELENKO & CO., INC. 99 BUSINESS PARK DR. Armonk, NY 10504 |
| Contact | Tribid Dasgupta |
| Correspondent | Tribid Dasgupta J.F. JELENKO & CO., INC. 99 BUSINESS PARK DR. Armonk, NY 10504 |
| Product Code | EJS |
| CFR Regulation Number | 872.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-06 |
| Decision Date | 1998-08-13 |