The following data is part of a premarket notification filed by Harry J. Bosworth Co. with the FDA for Harry J. Bosworth Resin I..
Device ID | K946317 |
510k Number | K946317 |
Device Name: | HARRY J. BOSWORTH RESIN I. |
Classification | Resin, Denture, Relining, Repairing, Rebasing |
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 | EBI |
CFR Regulation Number | 872.3760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-12-28 |
Decision Date | 1995-02-16 |