The following data is part of a premarket notification filed by Lunar Corp. with the FDA for Expert Spine Morphotietry Reference.
Device ID | K961007 |
510k Number | K961007 |
Device Name: | EXPERT SPINE MORPHOTIETRY REFERENCE |
Classification | Densitometer, Bone |
Applicant | LUNAR CORP. 313 WEST BELTLINE HIGHWAY Madison, WI 53713 |
Contact | Gary Syring |
Correspondent | Gary Syring 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 | 1996-03-12 |
Decision Date | 1996-07-25 |
Summary: | summary |