The following data is part of a premarket notification filed by J.f. Jelenko & Co., Inc. with the FDA for Suncast.
Device ID | K923720 |
510k Number | K923720 |
Device Name: | SUNCAST |
Classification | Alloy, Gold-based 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 | EJT |
CFR Regulation Number | 872.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-27 |
Decision Date | 1993-03-05 |