The following data is part of a premarket notification filed by Medi-globe Corp. with the FDA for Injectra Injection Needle.
| Device ID | K061222 |
| 510k Number | K061222 |
| Device Name: | INJECTRA INJECTION NEEDLE |
| Classification | Endoscopic Injection Needle, Gastroenterology-urology |
| 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 | FBK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-02 |
| Decision Date | 2006-07-03 |
| Summary: | summary |