The following data is part of a premarket notification filed by Polymer Technology Corp. with the FDA for Maclean-fogg, Disp. Base Mold.
Device ID | K831900 |
510k Number | K831900 |
Device Name: | MACLEAN-FOGG, DISP. BASE MOLD |
Classification | Container, Embedding |
Applicant | POLYMER TECHNOLOGY CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KER |
CFR Regulation Number | 864.3010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-06-14 |
Decision Date | 1983-07-28 |