The following data is part of a premarket notification filed by Mdt Corp., Inc. with the FDA for Dental Light.
Device ID | K926081 |
510k Number | K926081 |
Device Name: | DENTAL LIGHT |
Classification | Light, Operating, Dental |
Applicant | MDT CORP., INC. 1777 EAST HENRIETTA RD.(14623) P.O. BOX 23077 Rochester, NY 14692 |
Contact | Mark N Smith |
Correspondent | Mark N Smith MDT CORP., INC. 1777 EAST HENRIETTA RD.(14623) P.O. BOX 23077 Rochester, NY 14692 |
Product Code | EAZ |
CFR Regulation Number | 872.4630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-01 |
Decision Date | 1994-01-26 |