The following data is part of a premarket notification filed by Harry J. Bosworth Co. with the FDA for Bosworth Impression Material I.
Device ID | K960063 |
510k Number | K960063 |
Device Name: | BOSWORTH IMPRESSION MATERIAL I |
Classification | Material, Impression |
Applicant | HARRY J. BOSWORTH CO. 7227 NORTH HAMLIN AVE. Skokie, IL 60076 |
Contact | Jmildres M Goldstein |
Correspondent | Jmildres 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 | 1996-01-05 |
Decision Date | 1996-02-14 |