The following data is part of a premarket notification filed by Medi-globe Corporation with the FDA for Sonotip Ii Ultrasound Needle System.
| Device ID | K070129 |
| 510k Number | K070129 |
| Device Name: | SONOTIP II ULTRASOUND NEEDLE SYSTEM |
| Classification | Biopsy Needle |
| Applicant | MEDI-GLOBE CORPORATION 110 WEST ORION #136 Tempe, AZ 85283 |
| Contact | Scott Karler |
| Correspondent | Neil E Devine INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-01-16 |
| Decision Date | 2007-01-31 |
| Summary: | summary |