The following data is part of a premarket notification filed by Owen Mumford Usa, Inc. with the FDA for Unifine Pentips.
| Device ID | K973899 |
| 510k Number | K973899 |
| Device Name: | UNIFINE PENTIPS |
| Classification | Needle, Hypodermic, Single Lumen |
| 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 | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-14 |
| Decision Date | 1997-12-04 |
| Summary: | summary |