The following data is part of a premarket notification filed by Den-tal-ez Mfg Co., Inc. with the FDA for Accessory To Improved Dental Operating Light.
Device ID | K925629 |
510k Number | K925629 |
Device Name: | ACCESSORY TO IMPROVED DENTAL OPERATING LIGHT |
Classification | Light, Operating, Dental |
Applicant | DEN-TAL-EZ MFG CO., INC. 1816 COLONIAL VILLAGE LN. Lancaster, PA 17601 |
Contact | William A.lambertson |
Correspondent | William A.lambertson DEN-TAL-EZ MFG CO., INC. 1816 COLONIAL VILLAGE LN. Lancaster, PA 17601 |
Product Code | EAZ |
CFR Regulation Number | 872.4630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-11-06 |
Decision Date | 1993-11-23 |