The following data is part of a premarket notification filed by Sectra Ab with the FDA for Sectra Angiography Package And Sectra Cardiology Package.
| Device ID | K034059 |
| 510k Number | K034059 |
| Device Name: | SECTRA ANGIOGRAPHY PACKAGE AND SECTRA CARDIOLOGY PACKAGE |
| Classification | System, Image Processing, Radiological |
| Applicant | SECTRA AB 1100 LAKEVIEW BLVD. Denton, TX 76208 |
| Contact | Carl Alletto |
| Correspondent | Carl Alletto SECTRA 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 | 2003-12-31 |
| Decision Date | 2004-03-09 |
| Summary: | summary |