The following data is part of a premarket notification filed by Philips Children's Medical Ventures with the FDA for Oral/enteral Syringes.
| Device ID | K100099 |
| 510k Number | K100099 |
| Device Name: | ORAL/ENTERAL SYRINGES |
| Classification | Tube, Feeding |
| Applicant | PHILIPS CHILDREN'S MEDICAL VENTURES 191 WYNGATE DRIVE Monroeville, PA 15146 |
| Contact | Lisa Casavant |
| 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 | 2010-01-13 |
| Decision Date | 2010-06-14 |
| Summary: | summary |