The following data is part of a premarket notification filed by Marcal Medical, Inc. with the FDA for Subcutaneous Needle Infusion Set.
| Device ID | K082818 |
| 510k Number | K082818 |
| Device Name: | SUBCUTANEOUS NEEDLE INFUSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | MARCAL MEDICAL, INC. 962 ALLEGRO LANE Apollo Beach, FL 33572 |
| Contact | Arthur Ward |
| Correspondent | Arthur Ward MARCAL MEDICAL, INC. 962 ALLEGRO LANE Apollo Beach, FL 33572 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-25 |
| Decision Date | 2008-12-23 |
| Summary: | summary |