The following data is part of a premarket notification filed by Strato Medical Corp. with the FDA for Lifeport Attachable System W/inducer Kit Lps 5555.
| Device ID | K915273 |
| 510k Number | K915273 |
| Device Name: | LIFEPORT ATTACHABLE SYSTEM W/INDUCER KIT LPS 5555 |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | STRATO MEDICAL CORP. PFIZER HOSPITAL PRODUCTS GROUP 123 BRIMBAL AVE Beverly, MA 01915 |
| Contact | Grace T.mcfall |
| Correspondent | Grace T.mcfall STRATO MEDICAL CORP. PFIZER HOSPITAL PRODUCTS GROUP 123 BRIMBAL AVE Beverly, MA 01915 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-25 |
| Decision Date | 1993-07-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H787LPS55550 | K915273 | 000 |