The following data is part of a premarket notification filed by Sectra-imtec Ab with the FDA for Sectra Osteoporosis Package.
| Device ID | K021527 |
| 510k Number | K021527 |
| Device Name: | SECTRA OSTEOPOROSIS PACKAGE |
| Classification | Densitometer, Bone |
| Applicant | SECTRA-IMTEC AB 1100 LAKEVIEW BLVD. Denton, TX 76208 |
| Contact | Carl Alletto |
| Correspondent | Carl Alletto SECTRA-IMTEC AB 1100 LAKEVIEW BLVD. Denton, TX 76208 |
| Product Code | KGI |
| CFR Regulation Number | 892.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-10 |
| Decision Date | 2002-06-07 |
| Summary: | summary |