AMIELLE
Stent, Vaginal
Owen Mumford USA, Inc.
The following data is part of a premarket notification filed by Owen Mumford Usa, Inc. with the FDA for Amielle.
Pre-market Notification Details
| Device ID | K983045 |
| 510k Number | K983045 |
| Device Name: | AMIELLE |
| Classification | Stent, Vaginal |
| Applicant | Owen Mumford USA, Inc. 849 PICKENS INDUSTRIAL DR. SUITE 14 Marietta, GA 30062 |
| Contact | Robert E Shaw |
| Correspondent | Robert E Shaw Owen Mumford USA, Inc. 849 PICKENS INDUSTRIAL DR. SUITE 14 Marietta, GA 30062 |
| Product Code | KXP |
| CFR Regulation Number | 884.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-01 |
| Decision Date | 1998-11-25 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00384702190017 | K983045 | 000 |
| 00384702101013 | K983045 | 000 |
| 00384702102010 | K983045 | 000 |
| 00384702103017 | K983045 | 000 |
| 00384702104014 | K983045 | 000 |
| 00384702105011 | K983045 | 000 |
| 00384702171016 | K983045 | 000 |
| 00384702172013 | K983045 | 000 |
| 00384702173010 | K983045 | 000 |
| 00384702174017 | K983045 | 000 |
| 00384702178015 | K983045 | 000 |
| 00384702179012 | K983045 | 000 |
| 00384702100030 | K983045 | 000 |
Trademark Results [AMIELLE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AMIELLE 86102398 5061716 Live/Registered |
Owen Mumford Limited 2013-10-25 |
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