The following data is part of a premarket notification filed by Harry J. Bosworth Co. with the FDA for Clear Liner.
Device ID | K842576 |
510k Number | K842576 |
Device Name: | CLEAR LINER |
Classification | Resin, Denture, Relining, Repairing, Rebasing |
Applicant | HARRY J. BOSWORTH CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EBI |
CFR Regulation Number | 872.3760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-07-03 |
Decision Date | 1984-09-27 |