The following data is part of a premarket notification filed by Owen Mumford Usa, Inc. with the FDA for Autojet 2 (non-fixed Needle Type).
| Device ID | K993385 |
| 510k Number | K993385 |
| Device Name: | AUTOJET 2 (NON-FIXED NEEDLE TYPE) |
| Classification | Introducer, Syringe Needle |
| Applicant | Owen Mumford USA, Inc. 849 PICKENS INDUSTRIAL DR. SUITE 14 Marietta, GA 30062 |
| Contact | Robert Shaw |
| Correspondent | Robert Shaw Owen Mumford USA, Inc. 849 PICKENS INDUSTRIAL DR. SUITE 14 Marietta, GA 30062 |
| Product Code | KZH |
| CFR Regulation Number | 880.6920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-08 |
| Decision Date | 1999-11-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00384701311017 | K993385 | 000 |
| 47612799202391 | K993385 | 000 |