The following data is part of a premarket notification filed by Pharmacia Deltec, Inc. with the FDA for Port-a-cath Portal Introducer Forceps.
Device ID | K881690 |
510k Number | K881690 |
Device Name: | PORT-A-CATH PORTAL INTRODUCER FORCEPS |
Classification | Port & Catheter, Implanted, Subcutaneous, Intraventricular |
Applicant | PHARMACIA DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
Contact | Edward Numainville |
Correspondent | Edward 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 | 1988-04-19 |
Decision Date | 1988-05-20 |