The following data is part of a premarket notification filed by Crown Delta Corp. with the FDA for Two Component Rtv Vinyl Silicone Mater.
Device ID | K843145 |
510k Number | K843145 |
Device Name: | TWO COMPONENT RTV VINYL SILICONE MATER |
Classification | Material, Impression |
Applicant | CROWN DELTA CORP. 142 GARTH ROAD Scarsdale , NY 10583 - |
Contact | Laurence Colin |
Correspondent | Laurence Colin CROWN DELTA CORP. 142 GARTH ROAD Scarsdale , NY 10583 - |
Product Code | ELW |
CFR Regulation Number | 872.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-08-10 |
Decision Date | 1984-10-18 |