The following data is part of a premarket notification filed by Ash-usa with the FDA for Rite-angle Disposable Prophy Angles.
Device ID | K954802 |
510k Number | K954802 |
Device Name: | RITE-ANGLE DISPOSABLE PROPHY ANGLES |
Classification | Handpiece, Contra- And Right-angle Attachment, Dental |
Applicant | ASH-USA 570 WEST COLLEGE AVE. York, PA 17404 |
Contact | P. Jeffery Lehn |
Correspondent | P. Jeffery Lehn ASH-USA 570 WEST COLLEGE AVE. York, PA 17404 |
Product Code | EGS |
CFR Regulation Number | 872.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-10-19 |
Decision Date | 1995-11-08 |