The following data is part of a premarket notification filed by J.f. Jelenko & Co., Inc. with the FDA for Ptm-45.
Device ID | K881861 |
510k Number | K881861 |
Device Name: | PTM-45 |
Classification | Alloy, Gold-based Noble Metal |
Applicant | J.F. JELENKO & CO., INC. 99 BUSINESS PARK DR. Armonk, NY 10504 |
Contact | Marcy Kramer |
Correspondent | Marcy Kramer 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 | 1988-05-03 |
Decision Date | 1988-06-01 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PTM-45 73404900 1388762 Live/Registered |
PENNWALT CORPORATION 1982-12-06 |