The following data is part of a premarket notification filed by Den-tal-ez Mfg Co., Inc. with the FDA for Improved Dental Operating Light.
Device ID | K920017 |
510k Number | K920017 |
Device Name: | IMPROVED DENTAL OPERATING LIGHT |
Classification | Chair, Dental, With Operative Unit |
Applicant | DEN-TAL-EZ MFG CO., INC. 1816 COLONIAL VILLAGE LN. Lancaster, PA 17601 |
Contact | Gary Foss |
Correspondent | Gary Foss DEN-TAL-EZ MFG CO., INC. 1816 COLONIAL VILLAGE LN. Lancaster, PA 17601 |
Product Code | KLC |
CFR Regulation Number | 872.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-01-02 |
Decision Date | 1992-03-02 |