The following data is part of a premarket notification filed by Std Med, Inc. with the FDA for Std Med Primo Port Poly.
| Device ID | K080645 |
| 510k Number | K080645 |
| Device Name: | STD MED PRIMO PORT POLY |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | STD MED, INC. 5 WHITCOMB AVENUE Ayer, MA 01432 |
| Contact | Pamela Papineau |
| Correspondent | Pamela Papineau STD MED, INC. 5 WHITCOMB AVENUE Ayer, MA 01432 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-06 |
| Decision Date | 2008-05-02 |
| Summary: | summary |