The following data is part of a premarket notification filed by J.f. Jelenko & Co., Inc. with the FDA for Accu-star.
Device ID | K922446 |
510k Number | K922446 |
Device Name: | ACCU-STAR |
Classification | Alloy, Other Noble Metal |
Applicant | J.F. JELENKO & CO., INC. 99 BUSINESS PARK DR. Armonk, NY 10504 |
Contact | Costantino Volpe |
Correspondent | Costantino Volpe 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 | 1992-05-22 |
Decision Date | 1992-08-05 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ACCU-STAR 76116853 not registered Dead/Abandoned |
Accu-Star Systems, Inc. 2000-08-25 |