The following data is part of a premarket notification filed by Beaverstate Dental, Inc. with the FDA for Model A15-101.
Device ID | K953191 |
510k Number | K953191 |
Device Name: | MODEL A15-101 |
Classification | Light, Fiber Optic, Dental |
Applicant | BEAVERSTATE DENTAL, INC. 19425 S.W. 89TH AVE. Tualatin, OR 97062 -8537 |
Contact | Chuck Whisman |
Correspondent | Chuck Whisman BEAVERSTATE DENTAL, INC. 19425 S.W. 89TH AVE. Tualatin, OR 97062 -8537 |
Product Code | EAY |
CFR Regulation Number | 872.4620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-06-23 |
Decision Date | 1995-09-05 |