The following data is part of a premarket notification filed by Medi-globe Corp. with the FDA for Modification Of Gip/medi-globe Ultrasound Needle System.
| Device ID | K990220 |
| 510k Number | K990220 |
| Device Name: | MODIFICATION OF GIP/MEDI-GLOBE ULTRASOUND NEEDLE SYSTEM |
| Classification | Biopsy Needle |
| Applicant | MEDI-GLOBE CORP. 6202 SOUTH MAPLE AVE. # 131 Tempe, AZ 85283 |
| Contact | Michelle L Fields |
| Correspondent | Michelle L Fields MEDI-GLOBE CORP. 6202 SOUTH MAPLE AVE. # 131 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 | 1999-01-22 |
| Decision Date | 1999-03-31 |
| Summary: | summary |