The following data is part of a premarket notification filed by Lunar Corp. with the FDA for Lunar Dpx Densitometer.
Device ID | K953032 |
510k Number | K953032 |
Device Name: | LUNAR DPX DENSITOMETER |
Classification | Densitometer, Bone |
Applicant | LUNAR CORP. 313 WEST BELTLINE HIGHWAY Madison, WI 53713 |
Contact | Dick Mazess |
Correspondent | Dick Mazess LUNAR CORP. 313 WEST BELTLINE HIGHWAY Madison, WI 53713 |
Product Code | KGI |
CFR Regulation Number | 892.1170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-06-30 |
Decision Date | 1995-10-23 |