The following data is part of a premarket notification filed by Sectra-imtec Ab with the FDA for Sectra Orthopedic Package.
| Device ID | K031590 |
| 510k Number | K031590 |
| Device Name: | SECTRA ORTHOPEDIC PACKAGE |
| Classification | System, Image Processing, Radiological |
| 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 | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-21 |
| Decision Date | 2003-10-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350092810111 | K031590 | 000 |
| 07350092810463 | K031590 | 000 |
| 07350092810432 | K031590 | 000 |
| 07350092810401 | K031590 | 000 |
| 07350092810364 | K031590 | 000 |
| 07350092810258 | K031590 | 000 |
| 07350092810227 | K031590 | 000 |
| 07350092810029 | K031590 | 000 |
| 07350092810043 | K031590 | 000 |
| 07350092810081 | K031590 | 000 |
| 07350092810494 | K031590 | 000 |