The following data is part of a premarket notification filed by Medi-globe Corp. with the FDA for Gip/medi-globe Needle System For Ultrasonic Fna.
| Device ID | K935844 |
| 510k Number | K935844 |
| Device Name: | GIP/MEDI-GLOBE NEEDLE SYSTEM FOR ULTRASONIC FNA |
| Classification | Biopsy Needle |
| Applicant | MEDI-GLOBE CORP. 6202 SOUTH MAPLE AVE. # 131 Tempe, AZ 85283 |
| Contact | Brian J Karler |
| Correspondent | Brian J Karler 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 | 1993-12-08 |
| Decision Date | 1995-02-13 |