The following data is part of a premarket notification filed by Pentron Laboratory Technologies with the FDA for Jewel Cast Plus.
Device ID | K023502 |
510k Number | K023502 |
Device Name: | JEWEL CAST PLUS |
Classification | Alloy, Metal, Base |
Applicant | PENTRON LABORATORY TECHNOLOGIES 53 NORTH PLAINS INDUSTRIAL RD. Wallingford, CT 06492 -0724 |
Contact | Greg Jimmie |
Correspondent | Greg Jimmie PENTRON LABORATORY TECHNOLOGIES 53 NORTH PLAINS INDUSTRIAL RD. Wallingford, CT 06492 -0724 |
Product Code | EJH |
CFR Regulation Number | 872.3710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-10-18 |
Decision Date | 2002-12-18 |
Summary: | summary |