The following data is part of a premarket notification filed by Vr Medical with the FDA for Vr Medical Enteral Oral Syringe.
| Device ID | K110853 |
| 510k Number | K110853 |
| Device Name: | VR MEDICAL ENTERAL ORAL SYRINGE |
| Classification | Tube, Feeding |
| Applicant | VR MEDICAL 90 GAO XIN ROAD Zhouzhuang, CN 215325 |
| Contact | Lee Pan |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | FPD |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-03-28 |
| Decision Date | 2011-05-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30817522012784 | K110853 | 000 |
| 30817522011251 | K110853 | 000 |
| 30817522011268 | K110853 | 000 |
| 30817522011275 | K110853 | 000 |
| 30817522011282 | K110853 | 000 |
| 30817522011299 | K110853 | 000 |
| 30817522011305 | K110853 | 000 |
| 30817522012753 | K110853 | 000 |
| 30817522012760 | K110853 | 000 |
| 30817522012777 | K110853 | 000 |
| 30817522010001 | K110853 | 000 |