The following data is part of a premarket notification filed by Strato Medical Corp. with the FDA for Lifeport(r) 7 Inch Continuous Infusion Set.
| Device ID | K870581 |
| 510k Number | K870581 |
| Device Name: | LIFEPORT(R) 7 INCH CONTINUOUS INFUSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | STRATO MEDICAL CORP. 123 BRIMBAL AVE. P.O.B.3148 Beverly, MA 01915 |
| Contact | Fenton, Jr. |
| Correspondent | Fenton, Jr. STRATO MEDICAL CORP. 123 BRIMBAL AVE. P.O.B.3148 Beverly, MA 01915 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-11 |
| Decision Date | 1987-04-23 |