The following data is part of a premarket notification filed by Medi-globe Corporation with the FDA for Sonotip Ii 25-gauge Ultrasound Needle System, Models Gus-01-18-025 And Gus-01-27-025.
| Device ID | K083802 |
| 510k Number | K083802 |
| Device Name: | SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27-025 |
| Classification | Biopsy Needle |
| Applicant | MEDI-GLOBE CORPORATION 110 WEST ORION ST #136 Tempe, AZ 85283 |
| Contact | Scott Karler |
| Correspondent | Scott Karler MEDI-GLOBE CORPORATION 110 WEST ORION ST #136 Tempe, AZ 85283 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-22 |
| Decision Date | 2009-03-20 |
| Summary: | summary |