The following data is part of a premarket notification filed by Cooper Surgical with the FDA for Ten-year Fracture Risk Option And Siri Table Option For Norland Dxa Bone Densitometers.
| Device ID | K091325 |
| 510k Number | K091325 |
| Device Name: | TEN-YEAR FRACTURE RISK OPTION AND SIRI TABLE OPTION FOR NORLAND DXA BONE DENSITOMETERS |
| Classification | Densitometer, Bone |
| Applicant | COOPER SURGICAL 95 CORPORATE DR. Trumbull, CT 06611 |
| Contact | Thomas G Williams |
| Correspondent | John Monahan COOPER SURGICAL 31 Gordan Road Piscataway, NJ 08854 |
| Product Code | KGI |
| CFR Regulation Number | 892.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-05 |
| Decision Date | 2009-06-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00866955000478 | K091325 | 000 |