The following data is part of a premarket notification filed by Medi-globe Corp. with the FDA for Sonotip Ii Ultrasound Needle System.
| Device ID | K051247 |
| 510k Number | K051247 |
| Device Name: | SONOTIP II ULTRASOUND NEEDLE SYSTEM |
| Classification | Biopsy Needle |
| Applicant | MEDI-GLOBE CORP. 110 WEST ORION, SUITE 136 Tempe, AZ 85283 |
| Contact | Scott Karler |
| Correspondent | Scott Karler MEDI-GLOBE CORP. 110 WEST ORION, SUITE 136 Tempe, AZ 85283 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-16 |
| Decision Date | 2005-06-16 |
| Summary: | summary |