The following data is part of a premarket notification filed by Pharmacia Deltec, Inc. with the FDA for Port-a-cath Implantable Access System - Kit Conf..
| Device ID | K881493 |
| 510k Number | K881493 |
| Device Name: | PORT-A-CATH IMPLANTABLE ACCESS SYSTEM - KIT CONF. |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intraventricular |
| Applicant | PHARMACIA DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Contact | W Numainville |
| Correspondent | W Numainville PHARMACIA DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Product Code | LKG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-08 |
| Decision Date | 1988-05-20 |