The following data is part of a premarket notification filed by Harry J. Bosworth Co. with the FDA for Activator Paste.
Device ID | K994027 |
510k Number | K994027 |
Device Name: | ACTIVATOR PASTE |
Classification | Material, Impression |
Applicant | HARRY J. BOSWORTH CO. 7227 NORTH HAMLIN AVE. Skokie, IL 60076 |
Contact | Mildred M Goldstein |
Correspondent | Mildred M Goldstein HARRY J. BOSWORTH CO. 7227 NORTH HAMLIN AVE. Skokie, IL 60076 |
Product Code | ELW |
CFR Regulation Number | 872.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-11-26 |
Decision Date | 2000-04-13 |