The following data is part of a premarket notification filed by Strato Medical Corp. with the FDA for Strato Plast Introducer Kit(12 Fr) Lps 7113/modif.
| Device ID | K905843 |
| 510k Number | K905843 |
| Device Name: | STRATO PLAST INTRODUCER KIT(12 FR) LPS 7113/MODIF |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | STRATO MEDICAL CORP. 123 BRIMBAL AVE. P.O.B.3148 Beverly, MA 01915 |
| Contact | Nancy C Hall |
| Correspondent | Nancy C Hall STRATO MEDICAL CORP. 123 BRIMBAL AVE. P.O.B.3148 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 | 1990-12-27 |
| Decision Date | 1991-04-19 |