The following data is part of a premarket notification filed by Genyx Medical, Inc. with the FDA for Genyx Medical Injection Needle.
| Device ID | K990996 |
| 510k Number | K990996 |
| Device Name: | GENYX MEDICAL INJECTION NEEDLE |
| Classification | Endoscopic Injection Needle, Gastroenterology-urology |
| Applicant | GENYX MEDICAL, INC. 36 ARGONAUT, SUITE 100 Aliso Viejo, CA 92656 -1467 |
| Contact | Judy F Gordon |
| Correspondent | Judy F Gordon GENYX MEDICAL, INC. 36 ARGONAUT, SUITE 100 Aliso Viejo, CA 92656 -1467 |
| Product Code | FBK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-25 |
| Decision Date | 1999-06-18 |
| Summary: | summary |