The following data is part of a premarket notification filed by Anutra Medical, Inc. with the FDA for Anutra Feedback Aspiration Syringe.
| Device ID | K143757 |
| 510k Number | K143757 |
| Device Name: | ANUTRA Feedback Aspiration Syringe |
| Classification | Syringe, Piston |
| Applicant | ANUTRA MEDICAL, INC. 1000 PERIMETER PK, SUITE E Morrisville, NC 27560 |
| Contact | Cameron Perkins |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2014-12-31 |
| Decision Date | 2015-01-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858718005004 | K143757 | 000 |