The following data is part of a premarket notification filed by Lina Medical Cml Aps with the FDA for Lina-bag, Models Lb-60, Lb-100.
| Device ID | K030422 |
| 510k Number | K030422 |
| Device Name: | LINA-BAG, MODELS LB-60, LB-100 |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | LINA MEDICAL CML APS FORMERVANGEN 5 Glostrup, DK 2600 |
| Contact | Niels Kornerup |
| Correspondent | Niels Kornerup LINA MEDICAL CML APS FORMERVANGEN 5 Glostrup, DK 2600 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-10 |
| Decision Date | 2003-04-14 |
| Summary: | summary |