The following data is part of a premarket notification filed by Island Medical with the FDA for Kit, Intravenous Extension Tubing.
| Device ID | K893120 |
| 510k Number | K893120 |
| Device Name: | KIT, INTRAVENOUS EXTENSION TUBING |
| Classification | Set, Administration, Intravascular |
| Applicant | ISLAND MEDICAL 2386 SHANNON RD. Fernandina Beach, FL 32034 |
| Contact | William J Schroder |
| Correspondent | William J Schroder ISLAND MEDICAL 2386 SHANNON RD. Fernandina Beach, FL 32034 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-25 |
| Decision Date | 1989-07-27 |