The following data is part of a premarket notification filed by Strato/infusaid, Inc. with the FDA for Strato/infusaid Infuse-a-kit.
| Device ID | K953254 |
| 510k Number | K953254 |
| Device Name: | STRATO/INFUSAID INFUSE-A-KIT |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | STRATO/INFUSAID, INC. 1400 PROVIDENCE HIGHWAY Norwood, MA 02062 |
| Contact | Craig M Audet |
| Correspondent | Craig M Audet STRATO/INFUSAID, INC. 1400 PROVIDENCE HIGHWAY Norwood, MA 02062 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-12 |
| Decision Date | 1995-11-29 |